Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals
Date: 2023-12-07
Institutions: Directorate-General for Environment, European Commission
Subjects: European Agency for Safety and Health at Work, European Chemicals Agency, European Environment Agency, European Food Safety Authority, European Medicines Agency, chemical product, chemicals legislation, exchange of information, interinstitutional cooperation (EU), scientific report

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   EUROPEAN COMMISSION  Brussels, 7.12.2023  COM(2023) 783 final 2023/0455 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals   (Text with EEA relevance) {SWD(2023) 850 final}  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The European Union has developed a comprehensive regulatory framework for chemicals to 
ensure  a  high  level  of  protection  of  human  health  and  the  environment  from  the  harmful 
effects  of  chemicals  and  to  support  the  efficient  functioning  of  the  internal  market  for 
chemicals  while  also  promoting  the  competitiveness  and  innovation  of  EU  industry.  The 
framework consists of over 40 pieces of legislation addressing: (i) the production and placing 
on  the  market  of  chemicals  and  products  containing  chemicals;  (ii)  emissions  of  chemicals 
and  safety  of  (iii)  workers;  (iv)  consumer  products;  (v)  food  and  feed  stuff;  (vi)  and  the 
environment. 
The fitness check of the most relevant EU chemicals legislation1 concluded that, overall, this 
framework of Union acts delivers the intended results and is fit for purpose. However, there 
are  shortcomings  in  the  consistency  of  safety  assessments,  the  efficiency  of  the  underlying 
technical and scientific work, and the consistency of transparency rules. The implementation 
of  the  individual  legislative  instruments  is  supported  by  a  large  volume  of  technical  and 
scientific  work.  Depending  on  the  legislation  in  question,  the  work  is  initiated  by  different 
bodies at different points in time, using different data and carried out by different EU agencies 
(the European Chemicals Agency (‘ECHA’), the European Food Safety Authority (‘EFSA’), 
the European Environment Agency (‘EEA’) and the European Medicines Agency (‘EMA’)), 
scientific committees, expert groups, Commission departments and contractors.  

This sometimes leads to inconsistent outcomes of assessments for the same chemicals across 
different  legislation.  This  situation  also  implies  an  inefficient  use  of  resources  and  carries 
unnecessary  costs  –  from  operating  multiple  committees  conducting  similar  assessments, 
assessing  the  same  chemical  by  several  committees  or  bodies,  to  duplicating  supporting 
technical and scientific work with potentially diverging hazard or risk assessment outcomes. 
In  addition,  the  assessments  that  are  not  carried  out  by  the  EU  agencies  are  sometimes 
perceived  by  stakeholders  as  not  being  transparent  and  inclusive  enough  or  as  not  being  of 
sufficient scientific quality and robustness. 

Building  on  the  findings  of  the  fitness  check,  the  Commission  committed  in  the  European 
Green  Deal2  to  present  a  Chemicals  Strategy  for  Sustainability3  (‘the  Strategy’).  As  part  of 
this  work,  it  committed  to  start  using  the  ‘one  substance  –  one  assessment’  approach  to 
improve  the  efficiency,  effectiveness,  coherence  and  transparency  of  issuing  safety 
assessments of chemicals across different pieces of EU legislation.  

Overall, the one substance, one assessment approach focuses on the main factors influencing 
the efficiency, effectiveness, coherence and transparency of safety assessments. It covers: 

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Commission  Staff  Working  Document  Fitness  Check  of  the  most  relevant  chemicals  legislation 
(excluding  REACH),  as  well  as  related  aspects  of  legislation  applied  to  downstream  industries 
accompanying the document: Report from the Commission to the European Parliament, the Council, the 
European Economic and Social Committee and the Committee of the Regions: Findings of the Fitness 
Check  of  the most  relevant  chemicals  legislation  (excluding  REACH)  and  identified  challenges,  gaps 
and weaknesses (SWD(2019) 199). 

The European Green Deal. COM (2019) 640 final. 
The Chemicals Strategy for Sustainability COM (2020) 667 final. 

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•  Initiation of chemicals safety assessments.  This  means synchronising  and coordinating 
the initiation or triggering of assessments and assessing groups of substances instead of 
assessing substances individually, to the extent possible. 

•  Attribution  of  tasks.  This  involves  a  clear  allocation  of  responsibilities  to  bodies 
performing assessments, making good use of available expertise and resources, as well 
as ensuring the good cooperation between the parties involved. 

•  Information.  Ensuring  that  information  is  easily  findable,  accessible,  interoperable, 
secure, of high quality and shared and reused to ensure that assessors have access to all 
available data without technical or administrative burden. 

•  Methodologies.  The  methods  used  for  the  assessments  are  coherent  and,  to  the  extent 

possible, harmonised. 

•  Transparency. Ensuring a high level of transparency in performing assessments, as well 

as in the underlying scientific data and information on chemicals. 

Two  key  actions  set  out  in  the  Strategy  to  improve  the  overall  efficiency,  effectiveness, 
coherence and transparency are to: 

•  ‘rationalise  the  use  of  expertise  and  resources  by  proposing  the  reattribution  of 
technical  and  scientific  work  on  chemicals  performed  under  the  relevant  pieces  of 
legislation to European agencies, including work of the Scientific Committee on Health, 
Environmental and Emerging Risks and Scientific Committee on Consumer Safety’; 

•  ensure  ‘a  clear  attribution  of  responsibilities  and  good  cooperation  among  the 

European agencies’. 

The  Council4  welcomed  the  ‘one  substance,  one  assessment’  initiative  and  the  European 
Parliament5 welcomed the ‘one substance, one hazard assessment’ approach. 
The EU Action Plan ‘Towards Zero Pollution for Air, Water and Soil’6 further contributed to 
this  effort  through  commitments  to  consolidate  the  roles  of  the  European  Environment 
Agency and the Commission’s Joint Research Centre in close collaboration with the European 
Chemicals Agency, the European Food Safety Agency, the European Maritime Safety Agency 
and other relevant agencies as the EU’s Knowledge Centres of Excellence for Zero Pollution 
Monitoring and Outlook Framework. 

Re-attributing  existing  tasks  and  attributing  new  tasks  to  EU  agencies  require  targeted 
amendments  of  the  existing  pieces  of  chemicals  legislation.  The  preferred  technique  is  to 
attribute tasks by making amendments  when the individual  Union acts  are revised  for other 
purposes,  such  as  meeting  other  objectives  of  the  Strategy.  Therefore,  where  possible, 
relevant changes have already been proposed or will be proposed as part of the revisions of 
individual pieces of legislation or as part of new legislation as detailed in the section below. 

This  proposal  focuses  on  amending  those  pieces  of  legislation  that  are  not  currently  being 
revised. It proposes targeted amendments to attribute tasks in Regulation (EU) 2019/1021 on 

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Council Conclusions on Sustainable Chemicals Strategy of the Union, 2021. 
European  Parliament  resolution  of  10 July  2020  on  the  Chemicals  Strategy  for  Sustainability 
(2020/2531(RSP)) (OJ C 371, 15.9.2021, p.75). 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic and Social  Committee and the Committee of the Regions ‘Pathway to a Healthy Planet for 
All - EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil' (COM(2021) 400 final). 

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persistent  organic  pollutants7,  and  Regulation  (EU)  2017/745  on  medical  devices8.  The 
proposal also amends Regulation (EC) No 401/2009 establishing the European Environmental 
Agency9  and  Regulation  (EC)  No 178/2002  laying  down  the  general  principles  and 
requirements  of  food  law  and  establishing  the  European  Food  Safety  Authority10.  These 
amendments  will  ensure  good  cooperation  among  EU  agencies  on  all  aspects  involving  the 
consistency  and  efficiency  of  chemical  assessments.  These  include  the  development  of 
methodologies, data exchanges and reconciling divergence in scientific output. 

The objectives of the proposal are to ensure that: 

•  the  allocation  of  responsibilities  for  performing  the  assessments  and  the  underlying 
technical  and  scientific  work  on  chemicals  is  clear,  exploits  and  maximises  synergies 
and makes best use of available expertise and resources in EU agencies; 

•  the  deliverables  are  of  high  scientific  quality  and  the  procedures  are  transparent  and 

inclusive;  

•  there is good cooperation and coordination among players on all aspects underling the 

assessment of chemicals, including methodology development and data exchange. 

• 

Consistency with existing policy provisions in the policy area 

The proposal complements and is  consistent with  the re-attribution of tasks on chemicals to 
EU  agencies  already  proposed,  that  are  under  development  as  part  of  the  revisions  of 
individual pieces of legislation, or that are envisaged as part of new legislation.  

Attribution or re-attribution of tasks to EU agencies has been already proposed as part of: 

•  Directive (EU) 2020/2184 of the European Parliament and of the Council on the quality 

of water intended for human consumption11; 

•  Regulation (EU) 2022/2371 of the European Parliament and of the Council on serious 

cross-border threats to health12; 

•  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  concerning 

batteries and waste batteries13; 

•  Proposal for a Regulation of the European Parliament and of the Council on reporting of 
environmental data from industrial installations and establishing an Industrial Emissions 
Portal14; 

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Regulation  (EU)  2019/1021  of  the  European  Parliament  and  of  the  Council  of  20  June  2019  on 
persistent organic pollutants (OJ L 169 25.6.2019, p. 45). 
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117 5.5.2017, p. 1). 
Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the 
European Environment Agency and the  European Environment Information and Observation Network 
(OJ L 126 21.5.2009, p. 13). 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety 
Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002, p. 1). 
OJ L 435 23.12.2020, p. 1. 
OJ L 314 6.12.2022, p. 26. 
COM(2020) 798 final. 
COM(2022) 157 final. 

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•  Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  amending 
Directive  2010/75/EU  on  industrial  emissions  (industrial  pollution  prevention  and 
control)15; 

•  Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  amending 
Directive  2000/60/EC  establishing  a  framework  for  Community  action  in  the  field  of 
water policy, Directive 2006/118/EC on the protection of groundwater against pollution 
and deterioration and Directive 2008/105/EC on environmental quality standards in the 
field of water policy16; 

•  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  amending 
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances 
and mixtures17; 

•  Proposal for a Regulation of the European Parliament and of the Council on packaging 

and packaging waste18; 

•  Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  amending 

Directive 2000/53/EC on end-of-life vehicles19; 

•  Proposal for a Regulation of the European Parliament and of the Council on the safety 

of toys20; 

•  Commission  Implementing  Decision  (EU)  2022/1979  on  establishing  the  form  and 
databases for communicating the information referred to in Articles 18(1) and 21(3) of 
Directive  2012/18/EU  on  the  control  of  major-accident  hazards  involving  dangerous 
substances21. 

Attributing or re-attributing tasks to EU agencies are being considered as part of the following 
proposals in preparation: 

•  Proposal for a Regulation of the European Parliament and the Council on the European 

Chemicals Agency22; 

•  Proposal  for  a  Regulation  of  the  European  Parliament  and  the  Council  amending 
Regulation  (EC) No 1907/2006  concerning the Registration, Evaluation,  Authorisation 
and Restriction of Chemicals23; 

•  Proposal  for  a  Regulation  of  the  European  Parliament  and  the  Council  amending 

Regulation (EC) No 1223/2009 on cosmetic products24.  

The  proposed  provisions  on  the  development  of  methodologies  and  cooperation  among  EU 
agencies  complements  the  proposal  for  a  Regulation  of  the  European  Parliament  and  the 
Council25  amending  Regulation  (EC)  No 726/2004  laying  down  Union  procedures  for  the 

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COM(2022) 156 final/3 
COM(2022) 540 final. 
COM(2022) 748 final. 
COM(2022) 677 final. 
COM/2023/451 final. 
COM(2023) 462 final. 
OJ L 272 20.10.2022, p. 14. 
European Chemicals Agency – proposal for a basic regulation (europa.eu)  
Chemicals  legislation  –  revision  of  REACH  Regulation  to  help  achieve  a  toxic-free  environment 
(europa.eu)   
EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision) (europa.eu)  

COM/2023/193 final. 

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authorisation  and  supervision  of  medicinal  products  for  human  use  and  establishing  a 
European Medicines Agency, which contains similar provisions. 

This  proposal  relates  to  the  proposal  being  prepared  for  a  Regulation  of  the  European 
Parliament  and  the  Council  on  the  ECHA,  which  may  contain  similar  provisions  on 
methodologies  and  cooperation  among  EU  agencies  applicable  to  ECHA.  In  addition,  the 
ECHA  proposal  will  consider  restructuring  the  agency’s  scientific  committees  to  better 
manage the increased workload arising from the tasks re-attributed by means of this proposal 
and of those listed above. 

This  proposal  is  closely  linked  to,  and  part  of  the  same  ‘one  substance,  one  assessment’ 
legislative  package,  as  the  proposal  for  a  Directive  of  the  European  Parliament  and  the 
Council  amending  Directive  2011/65/EU26  as  regards  the  re-attribution  of  scientific  and 
technical tasks to the European Chemicals Agency, specifically amending Articles 5 and 6 of 
that Directive. Those amendments refer to the attribution of a role and specific tasks to ECHA 
and  its  scientific  committees  in  the  processes  for  substance  restrictions  and  assessing 
exemption requests corresponding to the restrictions, in line with existing procedures laid out 
in Regulation (EC) No 1907/200627 (‘the REACH Regulation’). 

This proposal also relates to other ‘one substance, one assessment’ actions announced in the 
chemicals  strategy  for  sustainability  –  in  particular  to  the  proposal  for  a  Regulation  of  the 
European  Parliament  and  the  Council  establishing  a  common  data  platform  on  chemicals, 
laying down rules to ensure that the data contained in it are findable, accessible, interoperable 
and  reusable  and  establishing  a  monitoring  and  outlook  framework  for  chemicals28.  That 
proposal  aims,  among  others,  to  encourage  the  sharing  and  re-using  of  chemicals  data  and 
information  among  EU  agencies  and  Member  State  competent  authorities.  This  will  further 
contribute to improving the consistency, efficiency and transparency of chemical assessments 
across  legislation.  It  will  also  attribute  several  new  tasks  to  EU  agencies  in  the  sharing  and 
generation of data, as well as in data and information management. 

• 

Consistency with other EU policies 

Attributing and re-attributing scientific and technical tasks in the assessment of chemicals to 
EU agencies is  consistent  with  the objectives of the Better Regulation  agenda. EU agencies 
benefit  from  robust  scientific  expertise  and  transparent  and  inclusive  processes,  which 
effectively  support  policymaking.  Consolidating  the  work  in  the  EU  agencies  and  thus 
lowering  the  number  of  bodies  involved  contributes  to  simplifying  and  standardising 
procedures and reducing administrative burdens. 

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Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction 
              of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, 
              p. 88). 

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Regulation  (EC)  No 1907/2006  of  the  European  Parliament  and  of  the  Council  of  18 December  2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No 793/93  and  Commission  Regulation  (EC)  No 1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (OJ L 396, 30.12.2006 , p.1). 
Proposal  for  a  Regulation  of  the  European  Parliament  and  the  Council  establishing  a  common  data 
platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, 
interoperable  and  reusable  and  establishing  a  monitoring  and  outlook  framework  for  chemicals 
(COM(2023) 779) 

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The  proposal  also  contributes  to  the  objectives  of  the  EU’s  data  and  digital  policies  by 
promoting the interoperability and machine-readability of chemical data held by EU agencies. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The legal basis for this proposal is Articles 43, 114, 207, 168(4)(c) and 192(1) of the Treaty 
on  the  Functioning  of  the  European  Union.  The  proposal  is  an  ‘omnibus’  regulation  that 
amends four regulations, each having their own legal bases. Regulation (EC) No 178/2002 is 
based on Article 43, 114, 207 and 168(4)(c), Regulation (EU) 2019/1021 is based on 192(1) 
TFEU, Regulation (EU) 2017/745 is based on Article 114 and Article 168(4)(c) TFEU, while 
Regulation 401/2009 is based on Article 192(1) TFEU. 

It  is  therefore  appropriate  to  base  this  Regulation  on  all  legal  bases  of  the  individual  acts 
being amended. 

• 

Subsidiarity (for non-exclusive competence) 

The initiative will revise and amend existing EU legal instruments in a targeted manner. The 
revisions  target  the  attribution  of  tasks  for  conducting  scientific  and  technical  work  at  EU 
level, which is necessary for the operation of those instruments. Given that the Member States 
are not in a position to ensure the re-attribution of tasks to the EU Agencies, which are EU 
bodies regulated at the EU level, the objective can only be achieved at  EU level, respecting 
thus the subsidiarity principle. 

• 

Proportionality 

The initiative does not go beyond what is necessary to achieve the desired objectives. 
The  accompanying  staff  working  document29  assesses  the  administrative  impact  of  the 
proposed revisions taking into account the re-attribution of other tasks to EU agencies in other 
legislative proposals. 

The scientific and technical tasks attributed to ECHA in this proposal are existing tasks that 
are similar to tasks that the agency already carries out under other pieces of legislation. The 
slight increase in administrative costs is proportionate to the added value of the re-attribution 
of  tasks.  The  added  value  stems  from  the  improved  quality  and  scientific  robustness  of  the 
assessments, the strengthened transparency and inclusiveness of the procedures, and improved 
consistency with assessments conducted under other pieces of legislation.  

In  the  long  term,  the  improved  consistency  of  EU  scientific  assessments  will  lead  to  better, 
more informed and more efficient policy choices for the benefit of the public, industry and the 
environment.  The  envisaged  amendments  will  also  reduce  administrative  burden  at  EU  and 
national levels due to more streamlined scientific work and the avoidance of duplication. 

• 

Choice of the instrument 

29  Commission  staff  working  document  accompanying  the  documents  Proposal  for  a  Regulation  of  the 
European Parliament and of the Council amending Regulations (EC) No 178/2002,  (EC) No 401/2009,  (EU) 
2017/745 and  (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of 
scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals and 
Proposal for a Directive of the European Parliament and the Council amending Directive 2011/65/EU of the 
European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the 
European Chemicals Agency (SWD (2023) 850) 

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The desired changes require targeted amendments of specific provisions related to roles and 
tasks of Agencies in scientific assessments. This requires amendment by means of a directly 
applicable Omnibus regulation of four regulations.  

RESULTS 

3. 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX POST 

OF 

EVALUATIONS, 

STAKEHOLDER 

• 

Ex post evaluations/fitness checks of existing legislation 

The  fitness  check  of  the  most  relevant  chemicals  legislation  (assessing  over  40  pieces  of 
legislation)  was  carried  out  in  201930.  It  concluded  that  overall,  the  legislation  delivers  the 
intended  results  and  is  fit  for  purpose.  However,  several  significant  weaknesses  prevent  the 
legislation from reaching its full potential. Across the  framework, it identified shortcomings 
in  the  consistency  of  safety  assessments,  the  efficiency  of  the  underlying  technical  and 
scientific  work,  and  the  consistency  of  transparency  rules.  These  shortcomings  can  lead  to 
inconsistent  safety  assessments,  slow  procedures,  inefficient  use  of  resources,  unnecessary 
burdens, a (perceived) lack of transparency, and an impact on the quality of scientific advice. 

The  fitness  check  also  showed  that  there  are  significant  opportunities  for  streamlining  the 
technical  and  scientific  work  through  EU  agencies.  This  would  improve  the  efficiency  of 
chemicals legislation (e.g. avoiding duplication of efforts and making the best use of available 
expertise  in  EU  agencies)  and  make  it  more  consistent  (e.g.  reducing  the  risk  of  different 
outcomes of hazard or risk assessments at EU level). It would also simplify the current set-up, 
improve the quality of assessments, and ensure predictability for stakeholders and the public. 

This proposal directly addresses the problems and opportunities identified in the fitness check. 

• 

Stakeholder consultations 

A  call  for  evidence  for  the  initiative  on  making  the  best  use  of  EU  agencies  to  streamline 
scientific assessments was published on the Commission Have your say website on 15 March 
2022. The public and stakeholders were invited to provide feedback up until 12 April 2022. In 
total,  65  submissions  were  received.  Most  submissions  were  received  from  business 
associations and companies (around 70% of submissions), followed by submissions from EU 
citizens  (11%),  non-governmental  organisations  (6%),  public  authorities  (6%),  others  (5%) 
and academic/research institutions (1.5%).  

Generally,  there  was  a  large  support  of  the  initiative  among  the  respondents  for  the  ‘one 
substance, one assessment’ approach, as well as for the specific initiative on the reattribution 
of tasks.  67% of respondents expressed their explicit support, 23% did not express explicitly 
their  opinion  but  provided  relevant  advices  on  how  to  develop  the  one  substance,  one 
assessment  approach.  About  10%  expressed  doubts  about  usefulness  of  the  initiative  or 
opposition to the initiative. 

Stakeholders were also informed and consulted on the re-attribution of tasks to EU agencies 
during  the  Information  Session  on  One  Substance,  One  Assessment  with  Stakeholders 
held on 1 June 2022. Around 800 participants followed this event online.  

30 

Report  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European  Economic  And 
Social  Committee  and  the  Committee  of  the  Regions:  Findings  of  the  Fitness  Check  of  the  most 
relevant  chemicals  legislation  (excluding  REACH)  and  identified  challenges,  gaps  and  weaknesses 
(COM/2019/264 final). 

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An  extensive  discussion  on  re-attribution  of  tasks  to  EU  agencies  was  held  with 
representatives of Member States and EU agencies at the meetings of the Expert Group on 
One Substance, One Assessment31 on 2-3 June 2022 and on 30 March 2023. Representatives 
of  Member  States  and  EU  Agencies  participating  in  the  expert  group  meetings  were 
supportive to the initiative as well, providing concrete suggestions on the reattributions. 

Main input received from the consultations  

The feedback regarding the re-attribution of tasks to the EU agencies  received from the call 
for evidence and from Member States and EU agencies during meetings of the Expert Group 
on One Substance, One Assessment can be grouped in 6 areas:  

Level of centralisation 

Stakeholders and Member States suggested that re-attribution of work should not result in one 
agency  being  responsible  for  the  risk  evaluations  of  all  chemicals.  The  regulations  must 
clearly set out the responsibilities of each agency.   

This  suggestion  is  reflected in  the proposal.  The  proposal  does  not  reallocate tasks  between 
EU  agencies.  The  proposal  aims  to  only  re-attribute  those  tasks  carried  out  by  bodies  other 
than EU agencies.  

Expertise  

Stakeholders suggested that re-attributing tasks should be done based on the existing expertise 
in  the  agencies  to  ensure  that  the  agency  receiving  the  task  benefits  from  the  necessary 
expertise.  It  should  be  ensured  that  valuable  expertise  acquired  by  existing  bodies  is 
preserved. Expertise in risk assessments under the different regulations should stay with those 
agencies currently responsible for them. Each agency is best positioned to lead and carry out 
specific  assessments  because  of  their  extensive  experience  in  product-specific  matters,  e.g. 
EFSA for food use, EMA for medicines use. 

These suggestions are reflected in the proposal. The criteria used to decide which EU agency 
should carry out a certain task includes similarity with existing expertise and how the task fits 
with an agency’s core focus and mandate. The initiative and the proposal do not change the 
conditions for using data in the regulatory processes and maintains the ‘specialisation’ of the 
agencies. 

Resources  

Member  States  insisted  that  the  new  tasks  for  the  agencies  must  be  accompanied  by  the 
required  resources.  Re-attributing  work  should  not  lead  to  an  agency  or  committee  being 
unable to manage the workload and jeopardising the quality of the work. 

This  suggestion  is  reflected  in  the  proposal.  The  proposal  is  accompanied  by  a  detailed 
assessment of the EU agencies’ resource and capacity needs. The proposals for re-attributing 
tasks  (made  as  part  of  the  revisions  of  individual  pieces  of  legislation  or  as  part  of  this 
omnibus  proposal)  are  accompanied  with  proposals  of  financial  and  human  resources  to 
ensure that adequate resources are available taking into account synergies and economies of 
scale. 

Organisation of scientific committees  

Member  States  indicated  that  the  agencies’  committees,  especially  those  of  ECHA,  might 
need  reorganising  such  as  to  deal  with  the  increased  workload,  especially  insofar  as  the 

31 

Register of Commission expert groups and other similar entities (europa.eu). 

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8 

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committee for risk assessment (RAC) of ECHA has already now a high workload. Instead of 
creating  new  scientific  panels  or  committees,  the  agencies  should  preferably  reinforce  and 
reuse  the  existing  panels,  committees,  and  expert/working  groups.  In  any  event,  safety 
assessments should be performed by an independent panel, independent committee or expert 
group that is independent. 

This  suggestion is  partly  reflected  in  the  proposal.  The  resources  provided  for  this  proposal 
will  also  be  beneficial  for  the  involved  scientific  committees.  The  structure  of  ECHA 
committees  will  be  addressed  as  part  of  the  Proposal  for  Regulation  of  the  European 
Parliament and the Council on the European Chemicals Agency32, which is under preparation. 
All agencies’ scientific committees are independent and this is not changed. 

Tasks to re-attribute  

Some stakeholders and Member States suggested that the ECHA should be involved in hazard 
assessments as part of the assessment of food contact materials, and EFSA should be involved 
in  risk  assessments.  The  agencies  should  be  included  in  evaluating  cosmetic  ingredients, 
deriving  environmental  quality  standards  under  the  Water  Framework  Directive  and  in 
opinions on chemical substances in products (i.e., in toys). 

This  comment  is  reflected  in  the  proposal.  All  the  suggested  legislation  and  tasks  were 
considered for re-attribution, and the proposals have been either made or are in preparation. 

Assessment of potential impacts on business operators 

A few respondents from stakeholders suggested to carry out an impact assessment on the one 
substance,  one  assessment  initiative  to  ensure  that  possible  impacts  on  businesses  are 
considered sufficiently and that businesses are involved in developing the initiative. 

This  suggestion  is  reflected  in  the  proposal.  Although  no  formal  impact  assessment  was 
carried out, the impacts were assessed where relevant and possible in the accompanying staff 
working  document33,  with  particular  focus  on  the  impacts  on  EU  agencies’  resources.  The 
proposed measures will not imply costs to businesses or have significant economic impact at 
EU scale.  

• 

Collection and use of expertise 

The Commission considered input provided by the EU agencies concerned when it assessed 
which tasks are worth re-attributing to EU agencies, how they should be attributed, as well as 
potential effects on those agencies.  

• 

Impact assessment 

The  fitness  check  of  all  chemical  legislation  (excluding  REACH)  assessed  most  of  the 
challenges and risks addressed through this initiative and concluded that there are significant 
opportunities  for  streamlining  the  technical  and  scientific  work  through  EU  agencies. 
Moreover,  there  is  little  discretion  of  the  policy  choice  as  to  achieve  objectives  of  the 
initiative. The consolidation of the technical and scientific work on chemicals at the EU level 
is possible only in the EU Agencies. Therefore, no formal impact assessment was carried out. 
The  impacts  were  nevertheless  assessed  where  relevant  and  possible  in  the  accompanying 
staff working document34.  

32 
33 
34 

European Chemicals Agency – proposal for a basic regulation (europa.eu)   
SWD (2023) 850 
SWD (2023) 850 

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Overall,  this  proposal  is  expected  to  improve  the  efficiency,  effectiveness,  coherence  and 
transparency  of  EU  processes  for  chemical  assessments  for  the  benefit  of  all  stakeholders. 
Citizens and the environment will benefit from better protection from dangerous chemicals as 
a  result  of  more  efficient  and  effective  assessment  processes.  Companies  will  benefit  from 
more  harmonised  and  transparent  processes  across  legislation,  from  a  reduced  number  of 
bodies  involved  in  safety  and  risk  assessments,  as  well  as  from  strengthened  certainty 
regarding  the  validity  of  assessments.  Finally,  the  national  and  EU  authorities  will  benefit 
from  improved  efficiency  of  delivery  of  assessments  and  improved  public  trust  and 
acceptance of regulatory decisions.  

•  Improved scientific consistency and coherence of assessments – The reduced number 
of  actors  involved  in  the  scientific  and  technical  work,  as  well  as  an  increased 
cooperation  and  obligation  to  solve  divergent  opinions  among  agencies  leads  to 
improved coherence and scientific consistency - both across the various Union acts, and 
across  the  assessment  processes  laid  out  therein.  The  consolidation  of  work  allows  to 
better  align  priority  setting,  timelines,  processes,  and  methodologies  used  for  the 
assessments. It facilitates re-use of assessment insights developed under one Union act 
on chemicals in the assessment process of another.  

•  Improved robustness of assessment, trust and acceptance of regulatory decisions – 
The involvement of the EU agencies and their committees in the scientific and technical 
work  on  chemicals  adds  more  scientific  expertise,  ensures  high  quality  of  scientific 
advice and leads to improved robustness of assessments and thus their acceptance.  

•  Strengthen  independence  of  the  scientific  advice  –  Moving  scientific  and  technical 
work  on  chemicals  from  the  Commission,  ad  hoc  committees  or  consultants  to  EU 
agencies and their committees reinforces the independence of the scientific advice and 
the separation between science and policy or between risk assessment and management. 
Agencies are independent and their committees work under stricter conflict of interest 
avoidance  rules,  improving  guarantees  of  independent  scientific  advice  to  the 
Commission. 

•  Improved  transparency  –  The  involvement  of  the  EU  agencies  in  scientific  and 
technical  work  will  ensure  transparency  to  the  process  in  terms  of  overall  process 
transparency.  

•  Improved efficiency of delivery of assessments – Centralising assessment work in the 
EU  agencies  will  allow  the  re-use  of  capabilities,  the  re-use  of  knowledge  and 
experience, and the re-use of IT tools and support services. 

While the proposed measures will not imply costs to businesses or have significant economic 
impact at EU scale, the initiative will have a major impact on the EU agencies’ resource and 
capacity  needs.  This  impact  was  assessed  in  detail  quantitatively  in  cooperation  with  the 
agencies  concerned.  The  re-attribution  of  tasks  made  as  part  of  the  individual  pieces  of 
legislation were assessed as part of their respective impact assessments. For the re-attribution 
of  tasks  made  as  part  of  this  proposal  for  an  omnibus  regulation  amending  four  pieces  of 
legislation,  as  well  as  the  accompanying  proposal  for  a  Directive  amending  the  RoHS 
directive,  the  assessment  is  presented  in  the  staff  working  document35  accompanying  this 
proposal.  That  document  summarises  the  impact  of  all  re-attributed  tasks  and  assesses  their 
cumulative impact on the EU agencies. 

35 

SWD (2023) 850 

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 • 

Regulatory fitness and simplification 

The proposed re-attribution of tasks to EU agencies and the provisions requiring cooperation 
among EU agencies will improve the coherence, efficiency, effectiveness and transparency of 
the legal framework on chemicals as a whole, and especially of the chemical assessments. 

Re-attributing tasks to EU agencies will enable efficient use of resources as a result of: 

•  Re-using  existing  capabilities  on  hazard,  risk,  exposure  and  socio-economic 

assessments, development of committee opinions, stakeholder consultation; 

•  Re-using existing hazard and risk data; 

•  the economies of scale from reusing scientific support services and IT tools. 

The  proposed  re-attribution  of  tasks  and  obligations  on  agencies  to  cooperate  on  the 
development  of  methodologies  will  generate  added  value  in  terms  of  improving  scientific 
consistency  across  the  chemicals  legislation  and  the  scientific  quality  and  robustness  of 
assessments. In addition, re-attributing tasks will significantly improve the transparency and 
inclusiveness  of  the  processes.  It  will  also  guarantee  the  independence  of  the  processes  and 
ensure a separation between risk assessment and risk management. 

The  proposed  provisions  requiring  cooperation  among  agencies  on  exchanging  data  and 
setting formats and controlled vocabularies will promote interoperability of data and facilitate 
digitalisation. This is also important in achieving the objective of removing technical barriers 
to  sharing  data  strived  for  in  the  proposal  for  a  Regulation  establishing  a  common  data 
platform on chemicals, laying down rules to ensure that the data contained in it are findable, 
accessible, interoperable and reusable and establishing  a monitoring and outlook framework 
for chemicals.  

The proposal has an overall positive impact on companies, including on small and medium-
sized companies  and micro-enterprises. Centralising  the scientific and technical  work in  the 
EU agencies will reduce the number of committees, expert groups or assessors the companies 
need  to  interact  with  in  case  of  a  regulatory  action  on  a  chemical.  Furthermore,  assessment 
and  consultation  procedures  as  well  as  IT  tools  used  for  the  submission  of  data  and 
information  across  legislation  will  be  more  standardised  across  legislation,  thus  easier  to 
manage  and  follow.  Strengthening  the  coherence  of  assessments  across  legislation  and 
reducing  the  potential  for  divergent  scientific  outcomes  across  legislation  will  reduce  the 
uncertainty  for  companies  stemming  from  potential  divergent  scientific  outcomes  across 
legislation.  

• 

Fundamental rights 

The proposal has no implications for the protection of fundamental rights. 

4. 

BUDGETARY IMPLICATIONS 

The  annexed  financial  statement  relates  to  the  one  substance,  one  assessment  package, 
which includes: 

•  the current proposal, 

•  the  proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  amending 
Directive 2011/65/EU as regards the re-attribution of scientific and technical tasks to the 
European Chemicals Agency, and  

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11 

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•  the  proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
establishing a common data platform on chemicals, laying down rules to ensure that the 
data contained in it are findable, accessible, interoperable and reusable and establishing 
a monitoring and outlook framework for chemicals.  

The  financial  statement  also  covers  the  financial  implications  for  the  European  Chemicals 
Agency  and  the  European  Environment  Agency  of  the  proposals  already  adopted  by  the 
Commission  which  have  not  been  reflected  in  the  accompanying  legislative  financial 
statements, namely: 

•  Proposal for a Regulation of the European Parliament and of the Council on packaging 

and packaging waste36,  

•  Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council  amending 

directive 2008/98/EC on waste37, and  

•  Proposal  for  a  Regulation  on  Circularity  requirements  for  vehicle  design  and  on 

management of end-of-life vehicles38.  

The financial statement  shows the budgetary implications and the human resources required 
in the Commission, ECHA, EEA, EFSA and EMA. These impacts reflect both changes in the 
allocation  of  responsibilities  across  the  agencies  and  the  allocation  of  new  tasks  that  the 
agencies will carry out. The main impacts are: 

•  For  ECHA,  an  increase  of  the  EU  contribution  by  EUR  24,2  million  for  the  period 

2025-2027, and additional 17 TAs and 13 CAs; 

•  For EEA, an increase of the EU contribution by EUR 4,5 million for the period 2025-

2027 and additional 4 TAs and 2 CAs; 

•  For EFSA, additional 2 CAs without an increase of the EU contribution; 

•  Contribution/service level agreements with EFSA an EMA for an estimated amount of 
EUR 4,4 million for the period 2025-2027 to cover 3 CAs per year for EFSA, 3 CAs per 
year for EMA and operational budget. 

The  detailed  explanation  of  the  financial  needs  of  the  proposals  is  provided  in  the  financial 
statement and in the respective proposals.  

5. 

• 

OTHER ELEMENTS 

Implementation plans and monitoring, evaluation and reporting arrangements 

The efficiency in performing the attributed tasks in the EU agencies will be monitored as part 
of  the  regular  evaluation  of  the  agencies’  performance.  In  addition,  implementation  will  be 
evaluated  and  reported  on  as  part  of  the  review  or  reporting  obligations  of  each  piece  of 
legislation. 

Detailed explanation of the specific provisions of the proposal 

• 
Article 1 amends Regulation (EC) No 178/2002 (General Food Law Regulation)39. It includes 
provisions  enabling  EFSA  to  better  cooperate  and  coordinate  with  ECHA,  EMA  and  EEA. 

36 
37 
38 

COM (2022) 677 final. 
COM (2023) 420 final. 
COM (2023) 451 final. 

EN 

12 

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This  cooperation  would  lead  to  more  consistent  scientific  assessments  of  chemicals  and 
encourage  the  agencies  to  develop  consistent  scientific  opinions  and  methodologies,  taking 
into  account  specific  sectoral  characteristics.  The  provisions  on  data  and  information 
exchange would bring the EU a step closer to the one substance, one assessment goals. These 
provisions make greater interoperability possible and scientific processes more robust. 
Article 2 amends Regulation (EC) No 401/2009 (the EEA Founding Regulation)40. It includes 
streamlining  obligations  on  the  EEA  to  promote  and  coordinate  the  development  of 
assessment methodologies and places the cooperation obligation laid out under Article 1 for 
EFSA, also on the EEA. 
Article 3 amends Annex I of Regulation (EU) 2017/745 (the Medical Devices Regulation)41 
to task ECHA with updating existing guidelines on conducting the risk-benefit assessment of 
the  presence  of  phthalates  in  medical  devices.  The  agency  will  also  develop  guidelines  for 
other  substances,  which  are  classified  as  either  carcinogenic,  mutagenic  or  toxic  to 
reproduction, of category 1A or 1B or have endocrine disrupting properties for human health 
of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 (the 
CLP Regulation)42. 

Article 4 amends Regulation (EU) No 2019/1021 by giving the Commission the possibility to 
request  ECHA  to  develop  a  report  analysing  the  human  health,  environmental,  social,  and 
economic impact of introducing or modifying concentration limit values specified in Annexes 
IV  and  V  to  Regulation  (EU)  No 2019/1021  (POPs  Regulation)43.  Together  with  the  newly 
introduced  requirement  for  an  opinion  of  the  agency’s  Committee  for  Socio-Economic 
Analysis on the report and on the proposed concentration limit values therein, this report will 
provide the necessary expert support for the Commission to develop the required proposal to 
introduce or amend the concentration limits in those Annexes.  

Considering the highly technical nature of the amendments, this provision also introduces the 
adoption of amendments to Annexes IV and V by means of a delegated act. To promote the 
development of a comprehensive chemical exposure and toxicity knowledge base, as well as 
streamline  data  flows  in  line  with  the  one  substance,  one  assessment  policy  target,  the 
provision also diverts data flows on the presence of persistent organic pollutant substances in 
the  environment  to  EEA,  which  is  the  agency  responsible  for  collecting  occurrence  data  on 
chemicals in the environment. 

39 

40 

41 

42 

43 

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety 
Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). 
Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the 
European Environment Agency and the European Environment Information and Observation Network 
(OJ L 126, 21.5.2009, p. 13). 
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No 178/2002  and  Regulation  (EC) 
No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1). 
Regulation  (EU)  2019/1021  of  the  European  Parliament  and  of  the  Council  of  20 June  2019  on 
persistent organic pollutants (OJ L 169, 25.6.2019, p. 45). 

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2023/0455 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 
2019/1021 of the European Parliament and of the Council as regards the re-attribution 
of scientific and technical tasks and improving cooperation among Union agencies in the 
area of chemicals  

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Articles 43, 114, 168(4)(c), 192(1) and 207 thereof, 

Having regard to the proposal from the European Commission,  

After transmission of the draft legislative act to the national parliaments, 

Having regard to the opinion of the European Economic and Social Committee, 

Having regard to the opinion of the Committee of the Regions, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

The European Green Deal1 sets a high ambition for enabling the transition towards a 
toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability2 
(‘the Strategy’) is a crucial delivery of the zero-pollution ambition and introduces the 
‘one  substance,  one  assessment’  approach,  which  aims  to  improve  the  efficiency, 
effectiveness,  coherence, and transparency of safety  assessments of chemicals  across 
Union legislation.   

In  order  to  achieve  this  objective,  a  part  of  the  scientific  and  technical  work  on 
chemicals  performed  at  Union  level  in  support  of  Union  legislation  needs  to  be 
consolidated  in  the  relevant  Union  agencies,  while  obligations  on  Union  agencies  to 
cooperate for the development of assessment methodologies and exchange of data and 
information  should  be  introduced.  This  would  simplify  the  current  set-up,  improve 
quality and coherence of safety assessments across Union legislation and ensure more 
efficient use of existing resources.  

1 

2 

Communication from the Commission to the European Parliament, the European Council, the Council, 
the European Economic and Social Committee and the Committee of the Regions, The European Green 
Deal. COM (2019) 640 final. 
Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European 
Economic  and  Social  Committee  and  the  Committee  of  the  Regions,  Chemicals  Strategy  for 
Sustainability Towards a Toxic-Free Environment. COM (2020) 667 final 

EN 

14 

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(3) 

(4) 

(5) 

(6) 

The  reattribution  of  certain  existing  scientific  and  technical  tasks  to  the  European 
Chemicals  Agency,  as well as the attribution of  new tasks, were proposed as part of 
ongoing revisions of Union acts. This horizontal proposal aims to provide for further 
attribution of tasks in respect of those Union acts which are not in the process of being 
revised  and  is  necessary  in  order  to  ensure  that  the  European  Chemicals  Agency  is 
involved  in  tasks  pertaining  to  its  expertise  and  developed  capacities  on  chemicals. 
This  is  in  line  with  the  ‘one  substance,  one  assessment’  aim  to  ensure  that  technical 
and  scientific  work  is  performed  by  the  appropriate  Union  agency,  benefiting  from 
demonstrated  experience  and  established  tools  in  its  field.  The  proposal  for  a 
Regulation  is  accompanied  by  a  proposal  for  a  Directive  for  the  amendment  of 
Directive  2011/65/EU  of  the  European  Parliament  and  of  the  Council3,  aiming  to 
achieve the same objectives. 

As  part  of  the  coordinated  consolidation  and  attribution  of  tasks  under  the  ‘one 
substance, one assessment’ approach, provisions to allocate a mandate to the European 
Medicines  Agency  to  develop  and  cooperate  on  the  development  of  assessment 
methodologies, standard formats and controlled vocabularies and exchange of data and 
information on chemicals have been introduced in Article 138(1), subparagraphs (zd) 
and  (ze),  as  well  as  new  procedures  for  ensuring  the  coherence  between  scientific 
opinions  in  Article  139  of  the  proposal  for  a  Regulation  amending  Union 
pharmaceutical legislation. 4  

To  ensure  the  coherence  of  methodologies  for  assessments  related  to  chemicals  at 
Union  level,  all  relevant  Union  agencies  should  have  an  equal  mandate  to  develop 
such methodologies in the areas falling within their respective missions and should be 
subject  to  the  same  obligations  to  cooperate  amongst  each  other  to  develop  such 
methodologies.  

To  ensure  the  coherence  and  efficiency  of  assessments  related  to  chemicals  across 
Union  legislation,  it  is  also  important  to  enable  data  interoperability  and  easy 
exchange  of  data  between  the  relevant  Union  agencies,  as  well  as  to  encourage 
cooperation  on  the  development  of  standard  formats  and  controlled  vocabularies. 
Thus, to facilitate data exchange between agencies,  any new data formats defined by 
the  European  Food  Safety  Authority  or  by  the  European  Environmental  Agency 
should be set in cooperation with other relevant Union agencies working on chemicals. 
To this end, relevant provisions should be introduced in Regulation (EC) No 401/2009 
of the European Parliament and of the Council and, in Regulation (EC) No 178/2002 
of  the  European  Parliament  and  of  the  Council,  existing  provisions  should  be 
strengthened and, where relevant, new ones be introduced. Similar provisions should 
also  be  considered  to  be  proposed  for  a  strengthened  mandate  of  the  European 
Chemicals Agency in its founding regulation. 

(7) 

To  promote  the  coherence  and  efficiency  of  assessments  related  to  chemicals  across 
Union  legislation,  steps  should  be  taken  by  the  relevant  Union  agencies  to  avoid 

3 

4 

Directive  2011/65/EU  of  the  European  Parliament  and  of  the  Council  as  regards  the  re-attribution  of 
scientific and technical tasks to the European Chemicals Agency. 
Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures 
for  the  authorisation  and  supervision  of  medicinal  products  for  human  use  and  establishing  rules 
governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation 
(EU)  No  536/2014  and  repealing  Regulation  (EC)  No  726/2004,  Regulation  (EC)  No  141/2000  and 
Regulation  (EC)  No  1901/2006,  COM(2023)  193  final.  [OJ:Please  insert  correct  reference  once  the 
Regulation is adopted]. 

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15 

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(8) 

(9) 

divergent  scientific  opinions.  Existing  cases  of  divergent  opinions  have  lead  to 
increased uncertainty for operators, as well as to declined public trust in the scientific 
robustness  and  coherence  of  scientific  decision  making.  Proposals  to  address  and 
strengthen  procedures  for  resolving  divergence  of  scientific  opinions  concerning  the 
European  Medicines  Agency  with  other  scientific  bodies  is  proposed  as  part  of  the 
revision  of  Union  pharmaceutical  legislation.  Similar  provisions  should  also  be 
considered  to  be  proposed  for  a  strengthened  mandate  of  the  European  Chemicals 
Agency  in  its  founding  regulation,  whilst  such  provisions  are  not  relevant  and 
applicable  to  the  European  Environmental  Agency,  since  this  agency  does  not  issue 
scientific opinions on individual chemicals such as to be part in divergent outcomes.  

Correspondingly,  this  Regulation  aims  to  address  the  eventual  divergence  between 
scientific  opinions  of  the  European  Food  Safety  Authority  and  those  of  other  Union 
agencies.  Regulation  (EC)  No  178/2002  of  the  European  Parliament  and  Council 
already  contains  provisions  establishing  a  procedure  to  solve  divergent  scientific 
opinions. Those resolution procedures should be reinforced, in that the European Food 
Safety Authority and the other dissenting agency should be bound to  make their best 
effort to resolve the divergence on general scientific issues, and only when they are not 
able to resolve the divergence, should they refer to risk managers.  

In  the  more  specific  case  of  scientific  divergence  pertaining  to  the  hazard 
identification of chemical substances, a new procedure enabling the resolution  of the 
divergence  should  be  established.  This  procedure  should  enable  the  Commission  to 
request  the  European  Chemicals  Agency,  as  the  Union  agency  most  equipped  with 
expertise and capacity in hazard assessment, as well as long-standing experience with 
the  harmonised  classification  and  labelling  process,  to  develop  a  proposal  for 
harmonised  classification  and  labelling,  in  accordance  the  Regulation  (EC)  No 
1272/2008  of  the  European  Parliament  and  Council,  moving  closer  to  the  ‘one 
substance,  one  assessment’  vision  as  regards  uniformity  of  hazard  assessments  of 
chemicals  across  the  Union.  This  possibility  should  be  reflected  in  the  relevant 
provision  providing  for  the  resolution  of  diverging  scientific  opinions  laid  down  in 
Regulation (EC) No 178/2002. 

(10)  To comply with the obligation laid down in Section 10.4.3 of Annex I to Regulation 
(EU) 2017/745 of the European Parliament and of the Council5, the Commission has 
provided  the  Scientific  Committee  on  Health,  Environmental  and  Emerging  Risks 
(‘SCHEER’)  with  a  mandate  to  prepare  guidelines  on  the  benefit-risk  assessment  of 
the  presence  of  phthalates  which  are  classified  as  either  carcinogenic,  mutagenic  or 
toxic  to  reproduction  category 1A  or  1B,  or  which  have  endocrine  disrupting 
properties for which there is scientific evidence of probable serious effects to human 
health and which are identified in accordance with the procedure set out in Article 59 
of  Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the  Council6. 

5 

6 

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1–849). 

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The  SCHEER  issued  those  guidelines  in  2019  and  the  Commission  has  issued  a 
mandate to the SCHEER to perform a first update of those guidelines.  

(11)  To  comply  with  the  obligation  laid  out  in  Section  10.4.4.  of  Annex  I  to  Regulation 
(EU) 2017/745, the Commission should mandate the relevant scientific committee to 
prepare  guidelines  for  substances  other  than  phthalates  and  which  are  classified  as 
either carcinogenic, mutagenic or toxic to  reproduction category 1A or  1B,  or which 
have endocrine disrupting properties  for which there is scientific evidence of probable 
serious  effects  to  human  health  and  which  are  identified  in  accordance  with  the 
procedure  set  out  in  Article  59  of  Regulation  (EC)  No  1907/2006  of  the  European 
Parliament and of the Council. 

(12)  The  European  Chemicals  Agency  already  provides  scientific  advice  on  chemical 
substances,  including  on  phthalates,  endocrine  disruptors  and  carcinogens,  mutagens 
and  reproductive  toxicants  under  Regulation  (EC)  No  1907/2006.  Several  key 
capacities  of  the  agency  can  be  reused,  including  hazard,  risk,  exposure  and  socio-
economic  assessment  capacities,  the  Committee  opinion  development  and  IT 
capabilities  for  stakeholder  consultation  and  dissemination.  To  enable  timely  future 
updates on the presence of phthalates and to ensure that the appropriate Union agency 
develops  new  guidelines  on  other  substances  on  the  basis  of  the  latest  scientific 
evidence, these tasks should be attributed to the European Chemicals Agency. 

(13)  Taking account of the new hazard classes and criteria for classification, labelling and 
packaging  of  substances  introduced  by  Commission  Delegated  Regulation  (EU) 
2023/707 of 19 December 20227, reference to endocrine disruptors for human health, 
of Category 1, should be specified in 10.4.1., point (b) of Annex I of Regulation (EU) 
2017/745  in  light  of  the  relevance  of  that  hazard  class  to  the  type  of  substances  in 
medical devices. 

(14)  To  make  best  use  of  the  European  Chemicals  Agency’s  knowledge  and  expertise 
gained through its involvement in the nomination and assessment processes under the 
Stockholm  Convention  on  Persistent  Organic  Pollutants,  the  European  Chemicals 
Agency should, upon request, assist the Commission in complying with its obligation 
to amend Annexes IV and V to Regulation (EU) 2019/10218. Where the opinion of the 
Committee  for  Socio-Economic  analysis  is  required,  and  in  order  to  allow  for  the 
necessary  capacity  and  resources  for  the  effective  functioning  of  that  committee, 
Member  States  should  be  given  the  opportunity  to  cover  for  the  specific  expertise 
required for the effective performance of the task  by nominating experts. In order to 
ensure  that  the  Committee  for  Socio-Economic  analysis  benefits  from  sufficient 
resources,  when  the  committee  appoints  one  of  their  members  as  a  rapporteur,  that 
person, or his employer should be remunerated. 

(15) 

In order to amend certain non-essential elements of Regulation (EU) 2019/1021 of the 
European Parliament and of the Council, the power to adopt  acts in  accordance with 
Article  290  TFEU  should  be  delegated  to  the  Commission  in  respect  of  amending 
Annexes IV and V in order to adapt them to the changes to the list of substances set 

7 

8 

Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 
1272/2008  as  regards  hazard  classes  and  criteria  for  the  classification,  labelling  and  packaging  of 
substances and mixtures (OJ L 93, 31.3.2023, p. 7–39). 
Regulation  (EU)  2019/1021  of  the  European  Parliament  and  of  the  Council  of  20  June  2019  on 
persistent organic pollutants (OJ L 169, 25.6.2019, p. 45). 

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17 

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out  in  the  Annexes  to  the  Stockholm  Convention  or  the  Protocol  or  adapt  them  to 
scientific and technical progress.  

(16)  As  part  of  their  reporting  obligations  under  the  Regulation  (EU)  2019/1021  of  the 
European Parliament and of the Council, Member States must report to the European 
Chemicals  Agency  information  on  the  presence  of  substances  listed  in  Part  A  of 
Annex  III  in  the  environment.  The  use  of  the  Information  Platform  for  Chemical 
Monitoring (‘IPCHEM’) is encouraged as a means for Member States to comply with 
their  obligations  to  report  that  chemical  occurrence  data  and  to  simplify  and  reduce 
their  reporting  obligations.  Where  Member  States  make  data  available  through 
IPCHEM, they no longer need to report it to the European Chemicals Agency, as the 
agency may retrieve it from the platform.  

(17)  The revision of the Directive (EU) 2020/2184 of the European Parliament and of the 
Council9  requires  Member  States  to  share  with  European  Environmental  Agency  all 
chemical occurrence or monitoring data in water. Additionally, the monitoring data on 
the presence of POPs in air are already being reported by Member States to the EEA 
as  part  of  the  Union  air  quality  legislation.  The  proposal  for  a  Regulation  of  the 
European  Parliament  and  the  Council  establishing  a  common  data  platform  on 
chemicals,  laying  down  rules  to  ensure  that  the  data  contained  in  it  are  findable, 
accessible,  interoperable,  and  reusable  and  establishing  a  monitoring  and  outlook 
framework for chemicals10 will require all chemical occurrence data to be held by the 
EEA. As a result, chemical occurrence data provided to and held in IPCHEM by the 
Commission  will  thus  be  collected  and  held  by  the  EEA,  instead  of  by  the 
Commission.  Therefore,  it  is  necessary  to  simplify  the  reporting  obligations  for 
Member  States  to  ensure  that,  where  Member  States  have  already  submitted  that 
information to the EEA as part of fulfilling obligations required by the provisions of 
other pieces of Union environmental legislation, Member States should be considered 
to have fulfilled their reporting obligations under Regulation (EU) 2019/1021.  

(18)  Regulations  (EC)  No  178/2002,  (EC)  No  401/2009,  (EU)  2017/745  and  (EU) 

2019/1021 should therefore be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

 Article 1 

Amendments to Regulation (EC) No 178/2002  

Regulation (EC) No 178/2002 is amended as follows: 

(1) 

 in Article 23, the following point (m) is added: 

‘(m) to cooperate with the competent bodies in the Member States that carry out similar 
tasks  to  those  of  the  Authority  and  to  cooperate  with  other  scientific  bodies  established 
under  Union  law,  notably  the  European  Chemicals  Agency,  the  European  Medicines 
Agency,  and  the  European  Environment  Agency  on  the  provision  of  relevant  scientific 
opinions, on the exchange of data and information, including the possible establishment of 

9 

10 

Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the 
quality of water intended for human consumption (recast), (OJ L 435, 23.12.2020, p. 1–62). 
[OJ Please insert reference once proposal is adopted] 

EN 

18 

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related data formats and controlled vocabularies to facilitate such an exchange, and on the 
development of scientific methodologies for the assessment of chemicals.’; 

(2) 

Article 30 is replaced by the following:  

‘Article 30 

Diverging scientific opinions 

1. 

2. 

3. 

The  Authority  shall  take  the  necessary  and  appropriate  measures  to  monitor  and 
identify  at  an  early  stage  any  potential  source  of  divergence  between  its  scientific 
opinions  and  the  scientific  opinions  issued  by  other  bodies  carrying  out  similar 
tasks.  

Where the  Authority identifies a potential source of divergence, it shall contact  the 
body concerned in order to ensure that all relevant scientific or technical information 
is  shared  and  in  order  to  identify  the  potentially  contentious  scientific  or  technical 
issues.   

The Authority and the body concerned shall cooperate to resolve the divergence. If 
the  Authority  and  the  body  concerned  are  not  able  to  resolve  the  divergence,  they 
shall draw up a joint report. The report shall clearly outline the contentious scientific 
issues  and  identify  the  relevant  uncertainties  in  the  data  and  be  made  publicly 
available.  

Where the body concerned is a Union agency or a scientific committee, the Authority 
shall present the joint report to the Commission. 

Where relevant, and where the divergence concerns conflicting scientific opinions of 
the Authority and another Union body or agency  on whether a substance fulfils the 
criteria  laid  out  in  Annex  I  of  Regulation  (EC)  No  1272/2008  of  the  European 
Parliament  and  of  the  Council11,  the  Commission  may  request  the  European 
Chemicals Agency to prepare a proposal for harmonised classification and labelling 
of  substances  and,  where  appropriate,  specific  concentration  limits,  M-factors  or 
acute  toxicity  estimates,  or  a  proposal  for  revision  thereof  following  the  procedure 
laid  out  in  Article  37  of  Regulation  (EC)  No  1272/2008.  The  Authority  and  the 
Union  body  or  agency  concerned  shall  co-operate  with  the  European  Chemicals 
Agency in developing that proposal.’. 

Article 2 

Amendments to Regulation (EC) No 401/2009  

Regulation (EC) No 401/2009 is amended as follows: 

(1) 

in Article 2, the following point (p) is added:  

11 

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353 31.12.2008, p. 1 
– 1355. 

EN 

19 

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‘(p) to develop assessment methodologies related to chemicals in the fields falling within its 
mission.’;  

(2) 

in Article 15, the following paragraph 5 is added: 

‘5.  The  Agency  shall  cooperate  with  other  scientific  bodies  established  under  Union  law, 
notably  the  European  Chemicals  Agency,  the  European  Food  Safety  Authority,  and  the 
European  Medicines  Agency,  on the  exchange  of  data  and  information  on  chemicals, 
including  the  possible  establishment  of  related  data  formats  and  controlled  vocabularies  to 
facilitate  such  an  exchange,  and  on  the  development  of  scientific  methodologies  for  the 
assessment of chemicals.’. 

Article 3 

Amendments to Regulation (EU) 2017/745  

Annex I to Regulation (EU) 2017/745 is amended as follows: 

(1) 

in Section 10.4.1, point (b) is replaced by the following: 

‘(b) substances which are identified as endocrine disruptors for human health, of Category 1, 
in  accordance  with  Part  3  of  Annex  VI  to  Regulation  (EC)  No  1272/2008  of  the  European 
Parliament  and  of  the  Council12  and  substances  having  endocrine-disrupting  properties  for 
which there is scientific evidence of probable serious effects to human health and which are 
identified  in  accordance  with  the  procedure  set  out  in  Article  59  of  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  or  substances  having  endocrine 
disrupting properties relevant to human health identified in accordance with Regulation (EU) 
No 528/2012.’  

(2) 

in Section 10.4.2, point (d) is replaced by the following: 

‘(d) where applicable and available, the latest relevant guidelines in accordance with Sections 
10.4.3. and 10.4.4.’; 

(3) 

Section 10.4.3 is replaced by the following: 

‘10.4.3.   Guidelines on phthalates 

When deemed appropriate based on the latest scientific evidence, but at least every 5 years, 
the Commission shall request the European Chemicals Agency (ECHA) to update guidelines 
on  the  benefit-risk  assessment  of  the  presence  of  phthalates  which  belong  to  either  of  the 
groups  of  substances  referred  to  in  Section  10.4.1.,  points  (a)  and  (b).  The  benefit-risk 
assessment shall consider the intended purpose and context of the use of the device, as well as 
any available alternative substances and alternative materials, designs or medical treatments 

When appropriate or when requested by the Commission, ECHA shall consult the Committee 
for Risk Assessment and the Committee for Socio-economic Analysis.’; 

(4) 

Section 10.4.4 is replaced by the following: 

‘10.4.4.   Guidelines on other CMR and endocrine-disrupting substances 

12 

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006( OJ L 353 31.12.2008, p. 1 
). 

EN 

20 

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The Commission shall  request  ECHA to  prepare  guidelines as referred to  in Section 10.4.3. 
and  following  the  process  described  therein  also  for  other  substances  referred  to  in  Section 
10.4.1., points (a) and (b), where appropriate.’.  

Article 4 

Amendments to Regulation (EU) 2019/1021  

Regulation (EU) 2019/1021 is amended as follows: 

(1) 

Article 8(1) is amended as follows: 

(a) 

the following point (i) is added:  

‘(i) upon request from the Commission, and within 12 months from that request, draw up and 
provide  a  report  on  the  human  health,  environmental  and  socio-economic  impacts  of 
introducing or modifying concentration limit values specified in Annex IV or V.’  

(2) 

Article 8(1a) is added: 

‘1a. The report referred to in Article 8(1), point (i), shall contain the following information: 

(a) 

(b) 

(c) 

(d) 

as  appropriate,  information  on  human  health  and  environmental  impacts  of 
waste consisting of, containing or contaminated with POPs, including impacts 
on waste management; 

information  on  concentrations  and  mass  flows  of  POPs  in  relevant  waste 
streams and on waste treatment and treatment capacities; 

an  analysis  of  the  impacts  of  the  different  concentration  limit  values 
considered; 

a  duly  motivated  proposal  for  concentration  limit  values  to  be  introduced  in 
Annex IV and, as appropriate, in Annex V. 

The Agency shall, as soon as it receives the request referred to in the first subparagraph, point 
(i), publish on its website a notice that a report on a possible amendment of Annex IV or V 
will be prepared inviting all interested parties, including waste operators and users of recycled 
materials, to submit comments within 8 weeks. The Agency shall publish those comments on 
its website. 

At  the  latest  9  months  following  the  submission  of  that  report,  the  Committee  for  Socio-
economic Analysis of the Agency, set up pursuant to Article 76(1), point (d), of Regulation 
(EC) No 1907/2006 shall adopt an opinion on the report and on the concentration limit values 
proposed  therein.  For  the  purpose  of  adopting  an  opinion  on  the  report,  Article  87  of 
Regulation (EC) No 1907/2006 shall apply mutatis mutandis.  

The Agency shall submit the report and the opinion of the Committee for the Socio-economic 
Analysis on the concentration limit values to the Commission without delay.’; 

(3) 

in Article 13, paragraph 2 is replaced by the following: 

‘2.   Where a Member State shares the information referred to in paragraph 1, point (e), with 
the European Environmental Agency, that Member State shall indicate that in the report and 
the  Member State  shall  be  considered  to  have  fulfilled  its  reporting  obligations  under  that 
point. 

EN 

21 

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Where  the  information  referred  to  in  paragraph 1,  point  (e),  is  contained  in  the  report  of  a 
Member State  provided  to  the  Agency,  the  Agency  shall  transmit  the  information  to  the 
European Environmental Agency for compiling, storing and sharing that information’; 

(4) 

in Article 15, paragraph 2 is replaced by the following: 

‘2. The Commission is empowered to adopt delegated acts in accordance with Article 18, to 
amend Annexes IV and V to adapt them to the changes to the list of substances set out in the 
Annexes  to  the  Convention  or  the  Protocol  or  to  adapt  them  to  scientific  and  technical 
progress.’ 

(5) 

Article 18 is amended as follows: 

(a) 

 The first sentence of paragraph 2 is replaced by the following: 

‘2.      The  power  to  adopt  delegated  acts  referred  to  in  Articles  4(3),  10(2)  and  15  shall  be 
conferred on the Commission for a period of five years from 15 July 2019.’. 

(b) 

The first sentence of paragraph 3 is replaced by the following: 

‘3. The delegation of power referred to in Articles 4(3), 10(2) and 15 may be revoked at any 
time by the European Parliament or by the Council.’. 

(c) 

Paragraph 6 is replaced by the following: 

‘6. A delegated act adopted pursuant to Articles 4(3), 10(2) and 15 shall enter into force only 
if no objection has been expressed either by the European Parliament or by the Council within 
a period of two months of notification of that act to the European Parliament and the Council 
or  if,  before  the  expiry  of  that  period,  the  European  Parliament  and  the  Council  have  both 
informed the Commission that they will not object.’. 

Article 6 

Entry into force 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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LEGISLATIVE FINANCIAL STATEMENT 

EN 

1 

  EN 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

This financial legislative statement covers the impact of the following proposals: 

One substance, one assessment package: 

- Proposal for a Regulation of the European Parliament and of the Council amending 
Regulations  (EC)  No  178/2002,  (EC)  No  401/2009,  (EU)  2017/745  and  (EU) 
2019/1021  of  the  European  Parliament  and  of  the  Council  as  regards  the  re-
attribution of scientific and technical tasks and improving cooperation among Union 
agencies in the area of chemicals 

- Proposal for a Directive of the European Parliament and of the Council amending 
Directive 2011/65/EU as regards the re-attribution of scientific and technical tasks to 
the European Chemicals Agency 

-  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
establishing a common data platform on chemicals, laying down rules to ensure that 
the  data  contained  in  it  are  findable,  accessible,  interoperable  and  reusable  and 
establishing a monitoring and outlook framework for chemicals 

Proposals  already  adopted  by  the  Commission  and  attributting  new  tasks  to  the 
European Chemicals Agency or the European Environment Agency, for which the 
corresponding  resources  for  the  agencies  have  not  been  reflected  in  the 
accompanying legislative financial statements: 

-  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on 
packaging and packaging waste replacing and repealing Directive 1994/62/EC of the 
European (COM (2022) 677 final) 

- Proposal for a Directive of the European Parliament and of the Council amending 
Directive 2008/98/EC on waste (COM (2023) 420 final) 

-  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on 
circularity  requirements  for  vehicle  design  and  on  management  of  end-of-life 
vehicles,  amending  Regulations  (EU)  2018/858  and  2019/1020  and  repealing 
Directives 2000/53/EC and 2005/64/EC (COM(2023) 451 final). 

1.2. 

Policy area(s) concerned  

09 – Environment & Climate Change 

1.3. 

The proposal/initiative relates to:  

 a new action  

 a new action following a pilot project/preparatory action56  

 the extension of an existing action  

56 

As  referred  to  in  Article  58(2)(a)  or  (b)  of  Regulation  (EU,  Euratom)  2018/1046  of  the  European 
Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of 
the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) 
No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and 
Decision  No  541/2014/EU  and  repealing  Regulation  (EU,  Euratom)  No  966/2012  (Financial 
Regulation). OJ L 193 30.7.2018, p. 1 – 222. 

EN 

2 

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 a merger or redirection of one or more actions towards another/a new action  

1.4. 

Objective(s) 

1.4.1.  General objective(s)  

The  overall  aim  of  the  one  substance,  one  assessment  approach  and  of  the  three 
underlying  proposals  is  to  improve  the  coherence,  efficiency,  effectiveness  and 
transparency  of  safety  assessments  across  EU  chemicals  legislation  and  thus  to 
contribute  to  a  well-functioning  single  market  for  chemicals  and  a  high  level  of 
protection of human health and the environment from chemicals. 

Regarding the general objectives of the proposals for a regulation on Packaging and 
Packaging  Waste  (COM  (2022)  677  final),  for  a  directive  amending  waste 
framework  directive  (COM  (2023)  420  final)  and  for  a  regulation  on  Circularity 
requirements  for  vehicle  design  and  on  management  of  end-of-life  vehicles  (COM 
(2023) 451 final), please, refer to the legislative financial statements attached to the 
proposals. 

1.4.2. 

Specific objective(s) 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and 
(EU) 2019/1021  of the European Parliament and of the Council as regards the 
reattribution of scientific and technical tasks and improving cooperation among 
the Union agencies in the area of chemicals: 

1.  ensure  that  the  attribution  of  responsibilities  for  performing  the  assessments  and 
the underlying technical and scientific work on chemicals is clear, that it exploits and 
maximises  synergies  and  that  it  makes  the  best  use  of  available  expertise  and 
resources; 

2. ensure that the output of scientific and technical tasks is of high scientific quality 
and that the procedures are transparent and inclusive;  

3.  achieve  a  good  cooperation  among  all  players  on  all  aspects  relating  to  the 
assessment of chemicals (such as methodology development and exchange of data); 

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council 
amending  Directive  2011/65/EU  as  regards  the  reattribution  of  scientific  and 
technical tasks to the European Chemicals Agency 

1.  ensure  that  the  attribution  of  responsibilities  for  performing  the  assessments  and 
the underlying technical and scientific work on chemicals is clear, that it exploits and 
maximises  synergies  and  that  it  makes  the  best  use  of  available  expertise  and 
resources; 

2. ensure that the output of scientific and technical tasks is of high scientific quality 
and that the procedures are transparent and inclusive; 

3. ensure that procedures are more aligned with methodologies under other chemicals 
legislation, leading to increased consistency between existing policy provisions 

Proposal  for  a   Regulation  of  the  European  Parliament  and  of  the  Council 
establishing a common data platform on chemicals, laying down rules to ensure 
that the data contained in it are findable, accessible, interoperable and reusable 
and establishing a monitoring and outlook framework for chemicals:  

EN 

3 

  EN 

 develop  a  common  data  platform  bringing  together  chemicals  data  from 

1. 
multiple sources, including environmental sustainability-related data;  

ensure  that  information  contained  in  the  common  data  platform  is  secure,  of 

2. 
high quality, findable, accessible, interoperable and re-usable; 

enable  the  commissioning  of  testing  and  monitoring  of  substances  as  part  of 

3. 
the regulatory framework when further information is considered necessary; 

4. 
keep  records  of  studies  commissioned  or  carried  out  by  businesses  in  a 
chemicals  regulatory  context  and  set  up  an  early  warning  system  for  emerging 
chemical risks; 

5. 

establish a monitoring and outlook framework for chemicals. 

Regarding  the  specific  objectives  of  the  proposals  for  a  regulation  on  Packaging 
and  Packaging  Waste  (COM  (2022)  677  final),  for  a  directive  amending  waste 
framework directive (COM (2023) 420 final) and for a regulation on Circularity 
requirements  for  vehicle  design  and  on  management  of  end-of-life  vehicles 
(COM (2023) 451 final), please, refer to the legislative financial statements attached 
to the proposals.    

1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The expected results and impacts of the proposals for a Regulation of the European 
Parliament  and  the  Council  amending  Regulations  (EC)  No  178/2002,  (EC)  No 
401/2009,  (EU)  2017/745  and  (EU)  2019/1021  as  regards  the    reattribution  of 
scientific  and  technical  tasks  and  improving  cooperation  among  Union  agencies  in 
the  area  of  chemicals,  the  proposal  for  a  Directive  of  the  European  Parliament  and 
the Council amending Directive 2011/65/EU as regards the re-attribution of scientific 
and  technical  tasks  to  the  European  Chemicals  Agency  and  the  proposal  for  a 
Regulation of the European Parliament and the Council establishing a common data 
platform on chemicals, laying down rules to ensure that the data contained in it are 
findable,  accessible,  interoperable  and  reusable  and  establishing  a  monitoring  and 
outlook  framework for  chemicals  are improved effectiveness, efficiency,  coherence 
and  tranparency  of  assessment  of  chemicals  across  legislation.  In  more  concrete 
terms this include the following: 

Improved  scientific  consistency  and  coherence  of  assessments  -  Involving  less 
actors in the scientific and technical work and centralising the work in the agencies 
and requiring them to cooperate and resolve divergent opinions will lead to improved 
coherence  and  scientific  consistency  among  the  assessments  carried  out  under 
different  pieces  of  legislation.  The  consolidation  of  work  allows  to  better  align 
priority setting, timelines, processes and methodologies used for the assessments. It 
facilitates the reuse of assessment insights developed under one piece of legislation 
in the assessment under another piece of legislation. Centralising data on chemicals 
in  the  EU  agencies  and  being  able  to  use  it  creates  a  common  knowledge  base  on 
which  the  assessments  are  based  and  thus  further  promotes  coherence  of 
assessments.  

Improved  robustness  of  assessment,  trust  and  acceptance  of  regulatory 
decisions  -  Involvement  of  the  EU  agencies  and  their  committees  in  the  scientific 
and technical work on chemicals adds more scientific expertise, ensures high quality 
of scientific advice and leads to  improved robustness  of assessments and  thus  their 

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4 

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acceptance. Centralising data on chemicals in the EU agencies and being able to re-
use them will increase the knowledge base, improve the robustness of the scientific 
advice provided and increase the acceptance of conclusions and regulatory decisions. 
Knowing through the notifications of studies that all studies have been considered in 
the assessment further strengthens the trust of citizens in regulatory decisions. 

Strengthened  independence  of  the  scientific  advice  -  Moving  scientific  and 
technical  work  on  chemicals  from  Commission  services,  ad  hoc  committees  or 
consultants  to  EU  agencies  and  their  committees  reinforces  the  separation  between 
science and policy or between risk assessment and management. Agencies and their 
committees  work  under  stricter  conflict  of  interest  avoidance  rules,  improving 
guarantees of independent scientific advice to the Commission. 

Improved  transparency  -  Involvement  of  the  EU  agencies  in  scientific  and 
technical  work  will  ensure  transparency  to  the  process  in  terms  of  overall  process 
transparency;  publication  of  regulatory  intentions  of  EU  authorities  and application 
submission intentions via PACT improves predictability for all stakeholders; making 
all data and information available at one point increases the transparency. 

Improved  compliance  -  Compiling  information  on  legal  provisions  for  chemicals 
and on their regulatory reference values from all legal frameworks at one place and 
making it easily accessible facilitate comprehensive understanding of legal frames to 
which  specific  substance  adheres  to  and  improves  implementation  of  law  and  the 
compliance. 

Improved efficiency of delivery of assessments – centralising assessment work in 
the EU agencies will allow reuse of capabilities, reuse of knowledge and experience, 
balancing  the  workload  and  reuse  of  IT  tools  and  support  services.  Making  data 
accessible at  one place and making them re-usable will decrease the  administrative 
burden for the authorities when preparing assessments of chemicals. 

Improved findability, interoperability, accessibility and re-use of data  - this will 
be achieved by making the data available at one place, by removingtechnical barriers 
to  share  the  data  and  by  adopting  and  promoting  the  use  of  standard  formats  and 
controlled vocabularies. 

Having necessary data for performing assessments by establishing data generation 
mechanism allowing to commission studies when there is no other legal provisions to 
obtain them. 

Shorten reaction time between early signals of risks and regulatory measuers to 
mitigate  the  risks  and  thus  improved  protection  of  human  health  and  the 
environment via the establishement of the early warning and action system. 

For the expected results and impacts of the proposals for a regulation on Packaging 
and  Packaging  Waste  (COM  (2022)  677  final),  for  a  directive  amending  waste 
framework  directive  (COM  (2023)  420  final)  and  for  a  regulation  on  Circularity 
requirements  for  vehicle  design  and  on  management  of  end-of-life  vehicles  (COM 
(2023) 451 final), please, refer to the legislative financial statements attached to the 
proposals.  

1.4.4. 

Indicators of performance 

Specify the indicators for monitoring progress and achievements. 

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The  efficiency  in  performing  the  attributed  tasks  to  the  EU  agencies  will  be 
monitored  as  part  of  the  regular  evaluation  of  performance  of  the  Agencies.,  In 
addition, implementation will be evaluated and reported on as part of the review or 
reporting  obligations  of  each  piece  of  legislation  for  which  EU  agencies  provides 
support. 

An  implementation  and  monitoring  plan  for  the  establishment  of  common  data 
platform  is  documented  in  the  Project  Initiation  Document  (referenced  also  in 
support  of  the  assessment  of  impacts  in  the  accompanying  staff  working 
document57). It outlines developments steps, governance setup and population of the 
platform  by  the  different  data  providers  with  datasets  identified  for  a  minimum 
viable product. The progress through interim outputs until the ‘go-live’ version of the 
platform  within  36  months  after  entry  into  force  of  the  regulation  will  be  closely 
monitored.  Platform  governance  envisions  regular  reporting  on  its  operations 
including the effectiveness of work on interoperability i.e. the ingestion of individual 
chemical  datasets.  The  common  data  platform  itself  will  enable  monitoring  of 
associated activities such as the early warning system and the application of a data 
generation mechanism. The same applies to chemical indicators that are expected to 
the  8th  Environmental  Action  Plan  monitoring  framework58. 
contribute 
Assessment  by  the  standing  expert  group  on  one  substance-one  assessment  is 
expected to continuously monitor progress on interoperability and re-use of data and 
utility of the common data platform and its products. 

to 

Regarding  the  indicators  of  the  proposals  for  a  regulation  on  Packaging  and 
Packaging  Waste  (COM  (2022)  677  final),  for  a  directive  amending  waste 
framework  directive  (COM  (2023)  420  final)  and  for  a  regulation  on  Circularity 
requirements  for  vehicle  design  and  on  management  of  end-of-life  vehicles  (COM 
(2023) 451 final), please, refer to the legislative financial statements attached to the 
proposals. 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for 

roll-out of the implementation of the initiative 

One substance, one assessment package: 

Q4 2023 – Q2 2025: interinstitutional negotiation of the proposals 

Q3 2025: entry into force of the legal acts 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and 
(EU) 2019/1021 as regards the reattribution of scientific and technical tasks and 
improving cooperation among Union agencies in the area of chemicals:  

Q3  2025  onwards:  ECHA  performs  technical  and  scientific  work  for  the  POPs 
regulation and medical devices as of entry into force of the legal act.  

57 

58 

Commission  staff  working  document  accompanying  the  document  Proposal  for  a  Regulation  of  the 
European  Parliament  and  of  the  Council  establishing  a  common  data  platform  on  chemicals,  laying 
down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and 
establishing a monitoring and outlook framework for chemicals (COM (2023) 855). 
8th Environmental Action Plan (EAP) monitoring framework. COM (2022) 357 final. 

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Q3  2025  onwards:  EEA  and  EFSA  cooperate  in  the  relevant  areas  defined  by  the 
regulation as of entry into force of the legal act. 

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council 
amending  Directive  2011/65/EU  as  regards  the  re-attribution  of  scientific  and 
technical tasks to the European Chemicals Agency 

Q3  2026  onwards:  ECHA  performs  technical  and  scientific  work  for  the  RoHS 
Directive as of 1 year after the entry into force of the legal act. 

for 

a  Regulation 

of 
Proposal 
the Council   establishing  a  common  data  platform  on  chemicals,  laying  down 
rules  to  ensure  that  the  data  contained  in  it  are  findable,  accessible, 
interoperable  and  reusable  and  establishing  a  monitoring  and  outlook 
framework for chemicals: 

the European  Parliament and 

of 

Q3 2025 – Q2 2026: After the adoption of the legal act, the Commission shall adopt 
commission  decisions  to  establish  the  platform  steering  committee,  adopt  the 
implementation plan and adopt the governance scheme for the common data platform 
and its services. 

Q3  2025  –  Q2  2028:  The  common  data  platform  containing  at  least  the  minimum 
viable data   shall be established within 3 years of the entry into force of the legal act. 

Q3 2025 – Q2 2028: Six building blocks making up dedicated services are set up as 
part of the common data platform within 3 years of the entry into force of the legal 
act. These dedicated services are an information platform for chemical monitoring, a 
repository  of  reference  values,  a  database  of  study  notifications,  a  database  with 
information on regulatory processes, a database with information on the obligations 
under Union acts  on chemicals  and a repository  of standard  formats and  controlled 
vocabularies.  

Q3 2025 – Q2 2031 A database on environmental sustainability related information 
is set up as the seventh building block making up dedicated services of the common 
data platform. 

Q3  2025  –  Q2  2028:  Establishment  of  relevant  data  flows  via  the  agencies  at  the 
latest within 3 years of the entry into force of the legal act. 

Q3 2025 – Q2 2028: The Commission transfers any human biomonitoring it holds to 
the European Environment Agency and it shall transfer the chemicals data contained 
in the Information Platform for Chemical Monitoring to the relevant agencies. 

Q3  2025  –  Q2  2035:  All  relevant  data  are  made  available  via  the  common  data 
platform at the latest within 10 years of entry into force of the legal act. 

Q3 2025 – Q4 2035: Relevant data are made available to the common data platform 
in IUCLID format at the latest by 2035. 

Q3 2025 and onwards:  Member States provide information on regulatory processes 
on chemicals to ECHA. 

Q3  2025  and  onwards:  Agencies,  where  relevant,  specify  standard  formats  and 
controlled vocabularies 

Q4  2025  and  onwards:  Framework  of  indicators  is  set  up  in  2025  and  regularly 
updated. 

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Q3 2025 – Q2 2026: Early warning and action system is established within one year 
of the entry into force of the legal act. 

Q3 2025 and onwards: Observatory for specific chemicals with potential contribution 
to emerging chemical risks is set up in 2025 

Q3  2025  onwards:  Data  generation  mechanism  is  established  in  the  first  year  from 
the  entry  into  force  and  is  progressively  expanded  to  full  operation  after  two  years 
from the entry into force. 

Q3  2026  onwards:  Obligation  to  notify  studies  that  are  not  already  notified  under 
Article 32b of Regulation (EC) No 178/2002 starts applying from 1 year of entry into 
force of the legal act. 

Proposals for a regulation on Packaging and Packaging Waste (COM (2022) 677 
final),  for  a  directive  amending  waste  framework  directive  (COM  (2023)  420 
final) and for a regulation on Circularity requirements for vehicle design and on 
management of end-of-life vehicles (COM (2023) 451 final):  

- see legislative financial statements attached to the proposals.    

1.5.2.  Added  value  of  Union  involvement  (it  may  result  from  different  factors,  e.g. 
coordination gains, legal certainty, greater effectiveness or complementarities). For 
the purposes of this point 'added value of Union involvement' is the value resulting 
from  Union  intervention,  which  is  additional  to  the  value  that  would  have  been 
otherwise created by Member States alone. 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and 
(EU) 2019/1021 as regards the reattribution of scientific and technical tasks and 
improving cooperation among Union agencies in the area of chemicals,  

and 

for  a  Directive  of 

Proposal 
the 
Council amending  Directive  2011/65/EU  as  regards  the  re-attribution  of 
scientific and technical tasks to the European Chemicals Agency 

the  European  Parliament  and  of 

The  legal  proposals  on  reattribution  of  tasks  will  revise  and  amend  in  a  targeted 
manner the existing EU legal instruments. The revisions target the (re-)attribution of 
tasks  for  performing  scientific  and  technical  work  at  EU  level  necessary  for  the 
operation  of  those  instruments  and  the  cooperation  among  the  Union  agencies  in 
performing the scientific and technical work. This cannot be sufficiently achieved by 
the Member States alone, by reason of its scale and effects, and therefore can only be 
achieved at EU level.  

for  a  Regulation  of 

Proposal 
the  European  Parliament  and  of 
the Council establishing  a  common  data  platform  on  chemicals,  laying  down 
rules  to  ensure  that  the  data  contained  in  it  are  findable,  accessible, 
interoperable  and  reusable  and  establishing  a  monitoring  and  outlook 
framework for chemicals 

The  problem  of  chemicals  data  being  scattered  among  different  Union  agencies, 
Commission  services  and  at  Member  State  level  can  only  be  addressed  by 
improvements in information availability at Union level. The ultimate objective with 
respect  to  information  availability  and  information  sharing  is  to  bring  together  all 
chemicals  data  in  one  centrally  accessible  location,  which  by  definition  requires 

EN 

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action at Union level. A similar reasoning applies to the other identified objectives of 
this  legal  proposal  relating  to  incomplete  knowledge  bases  with  corresponding 
obligation  to  notify  launching  of  studies  planned  for  inclusion  in  EU  regulatory 
dossiers  (sister  provision  to  related  obligation  under  general  food  law),  data 
generation mechanism for the European Chemicals Agency, but also facilitate access 
to  data  generated  by  EU  research  and  run  dedicated  services  that  compile  specific 
information like reference values, collect information on environmental sustainability 
and  early  warning  signals  on  emerging  risks,  and  calculate  chemicals  related 
indicators.  

Proposals for a regulation on Packaging and Packaging Waste (COM (2022) 677 
final),  for  a  directive  amending  waste  framework  directive  (COM  (2023)  420 
final) and for a regulation on Circularity requirements for vehicle design and on 
management of end-of-life vehicles (COM (2023) 451 final): 

- see the legislative financial statements attached to the proposals.    

1.5.3.  Lessons learned from similar experiences in the past 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and 
(EU) 2019/1021 as regards the reattribution of scientific and technical tasks and 
improving cooperation among Union agencies in the area of chemicals,  

Proposal  for  a  Directive  of  the  European  Parliament  and  of  the  Council 
amending  Directive  2011/65/EU  as  regards  the  re-attribution  of  scientific  and 
technical tasks to the European Chemicals Agency, and 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council 
establishing a common data platform on chemicals, laying down rules to ensure 
that the data contained in it are findable, accessible, interoperable and reusable 
and establishing a monitoring and outlook framework for chemicals: 

The  EU  regulatory  framework  for  hazard  and  risk  assessment  and  management  of 
chemicals  is  comprehensive  and  consists  of  many  legislative  pieces,  addressing 
production and placing on the market of chemicals and chemical products, emissions 
of  chemicals  and  safety  of  workers,  consumer  articles,  food  and  feed  stuff  and  the 
environment.  

The fitness check of the most relevant chemicals legislation assessing over 40 pieces 
of  legislation  was  performed  in  201959.  It  concluded  that  overall  the  EU  chemicals 
legislation  delivers  results  as  intended  and  is  fit-for-purpose,  but  a  number  of 
significant weaknesses prevent the EU chemicals legislation from living up to its full 
potential. It identified shortcomings across legislative pieces as regards the coherence 
of safety assessments, efficiency of the underlying technical and scientific work and 
the  coherence  of  transparency  rules.  These  shortcomings  can  lead  to  inconsistency 
and incoherence in safety assessments, slow procedures, inefficient use of resources, 
unnecessary burden, (perceived) lack of transparency and impacts  on the quality  of 
scientific advice. 

59 

Report  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European  Economic  And 
Social  Committee  and  the  Committee  of  the  Regions:  Findings  of  the  Fitness  Check  of  the  most 
relevant  chemicals  legislation  (excluding  REACH)  and  identified  challenges,  gaps  and  weaknesses. 
COM/2019/264 final. 

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The  fitness  check  also  showed  that  there  are  significant  opportunities  for 
streamlining the technical and scientific work through EU agencies that would make 
the functioning of chemicals legislation more efficient (e.g. avoiding duplication of 
efforts  and  making  the  best  use  of  available  expertise  in  EU  agencies)  and  more 
coherent (e.g. reducing the risk of diverging outcomes of hazard/risk assessments at 
EU  level).  It  would  also  simplify  the  current  set-up,  reduce  the  need  to  provide 
information to multiple interlocutors, improve the quality of assessments, and ensure 
predictability for stakeholders and the general public. In addition, it would improve 
scientific  quality  and  robustness  of  some  assessments  and  ensure  better  separation 
between risk assessment and risk management. 

The  fitness  check  further  found  that  there  are  shortcomings  in  discoverability, 
accessibility and availability of good-quality and reliable data and in sharing and re-
using of data across legislative silos. Stakeholders have complained about this in the 
past (e.g. regarding inefficiencies caused by double reporting, difficulties to identify 
and access data, inconsistencies between outcomes of safety assessments as a result 
of  them  being  based  on different  datasets,  and  not  considering  all  available  data  in 
safety  assessments).  There  is  a  lack  of  awareness  of  interested  parties  (EU  bodies, 
authorities, industry, NGOs) of what information is available and where and how the 
existing  data  can  be  used  and  accessed,  and  re-use  rights  are  sometimes  too 
restrictive. Unnecessary duplication of effort in data generation still occurs in some 
instances due to a lack of data sharing as a result of various related factors including 
confidentiality  and  intellectual  property  rights.  A  more  comprehensive  approach 
across  the  EU  chemicals  legislation,  including  through  an  open  data  policy  and  a 
better  use  of  smart  technologies  was  identified  as  a  way  to  improve  the  overall 
efficiency  of  the  EU  legislative  framework  for  chemicals  and  contribute  to  the 
Commission’s commitment towards more transparency. 

Despite  the  comprehensive  and  advanced  EU  regulatory  framework  for  chemicals 
there  is  a  concern  that  it  lacks  the  relevant  mechanisms  to  adequately  address 
emerging  chemical  risks  in  a  timely  manner.  There  are  numerous  examples  of  the 
long  timespan between a signal of a risk and the adoption of adequate measures to 
address that risk60, which include the difficulty to get emerging chemical risks such 
as PFAS and endocrine disruptors, on the radar of policy makers and  governmental 
risk assessors. There is also an aspect of potential contribution to emerging risk due 
to potential inadequacy of existing systems, its assumptions and applied methods to 
cope with additional uncertainties brought by innovation, as has been the case with 
nanomaterials. To prevent damage caused by chemicals and help steer towards their 
safe and sustainable use, it is thus essential to be able to identify as early as possible 
emerging  chemical  risks  and  potential  contribution  to  them,  and  to  anticipate  to 
unforeseen  consequences  related  to  the  use  of  chemicals  and  their  release  into  the 
environment.  

To conserve natural resources and protect ecosystems and people, within the limits of 
our planet,  assessing  the environmental impacts generated by chemicals  along  their 
entire life cycle is  needed. Evaluation  of several  impact  categories, such  as climate 
change and resource use, requires access to robust and high-quality information and 
can  guide  the  design,  development  and  production  of  chemicals  that  provide  a 
desirable  function  or  service  while  being  safe  and  sustainable.  Moreover,  the 

60 

EEA:  Late  lessons  from  early  warnings:  the  precautionary principle  1896–2000,  Luxembourg:  Office 
for Official Publications of the European Communities, 2001 

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availability of sustainability information could trigger a demand for chemicals with 
lower  environmental  impacts,  and  therefore  have  direct  benefit  for  health  and  the 
environment. 

Proposals for a regulation on Packaging and Packaging Waste (COM (2022) 677 
final),  for  a  directive  amending  waste  framework  directive  (COM  (2023)  420 
final) and for a regulation on Circularity requirements for vehicle design and on 
management of end-of-life vehicles (COM (2023) 451 final): 

- see the legislative financial statements attached to the proposals.  

1.5.4.  Compatibility  with  the  Multiannual  Financial  Framework  and  possible  synergies 

with other appropriate instruments 

The initiative falls under the umbrella of the European Green Deal. The Green Deal 
recognises the advantages of investing in more digital Europe and it specifically calls 
to review how to use better the EU’s agencies and scientific bodies to move towards 
a  process  of  ‘one  substance,  one  assessment’  and  to  provide  greater  transparency 
when prioritising action to deal with chemicals. 

The initiative falls under Heading 3 (Natural Resources and the Environment), Title 
9  (Environment  and  Climate  Action)  of  the  Multiannual  Financial  Framework.  As 
detailed below, the implementation of this piece of legislation will require additional 
human resources and also some supporting expenditure. 

The  EU  funding  provided  on  research  and  innovation  via  the  Horizon  Europe  (e.g. 
PARC cooperative action) will complement this initiative. 

1.5.5.  Assessment  of  the  different  available  financing  options,  including  scope  for 

redeployment 

for 

a  Regulation 

of 
Proposal 
the Council  amending Regulations (EC)  No 178/2002,  (EC) No 401/2009,  (EU) 
2017/745  and  (EU)  2019/1021  as  regards  the  reattribution  of  scientific  and 
technical tasks and improving cooperation among Union Agencies in the area of 
chemicals  

the European  Parliament and 

of 

The  legislative  proposal  for  a  regulation  as  regards  the  reattribution  of  tasks  and 
improving cooperation among Union agencies in the area of chemicals will amend 2 
legislative  pieces  (POPs  Regulation  and  Medical  devices  regulation)  to  reattribute 
the assessment work under these pieces of legislation to ECHA and it will amend the 
regulation  on  the  European  Environment  Agency  and  the  regulation  on  general 
principles and requirements of food law and establishing the European Food Safety 
Authority to ensure better cooperation among agencies on methodology development 
and on exchange of data.  

Changes  to  POPs  regulation  will  reattribute  the  technical  assistance  in  reviewing 
Annexes IV and V to ECHA and hosting the POPs monitoring data to EEA. For this 
work, ECHA  will require  in  the first  year 1  FTE  (1 TA)  and operational  budget  of 
EUR  35  000  and  as  of  the  second  year  2  FTEs  (2  TAs)  per  year  and  operational 
budget  of  EUR  50  000  per  year.  No  resources  are  needed  for  EEA.  The  work  on 
reviewing the Annexes IV and V is currently performed by the Commission with the 
help  of  consultants  and  amounts  to  approximately  1.5  FTEs  per  year.  The 
involvement of ECHA and its Committee for Socio-Economic Analysis is envisaged 
to  provide  a  significant  increase  in  the  scientific  quality,  the  consistency,  the 
robustness  and  the  level  of  independence  of  the  assessments  upon  which  the 

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Commission  develops  its  proposals  on  this  matter.  The  hosting  of  chemicals 
monitoring  data  under  POPs  regulation  is  currently  done  by  the  by  Commission. 
Transfer  of  this  work  to  EEA  will  require  no  additional  resources,  as  POPs 
monitoring data in waters are to be reported to EEA under the water legislation and 
resources for that were proposed in the recent proposal, the POPs monitoring data in 
air  are  already  being  reported  to  EEA  as  part  of  the  air  quality  legislation  and 
covered by resources for that activity. The increase of the contribution to ECHA will 
be  compensated  by  a  reduction  of  the  LIFE  budget.  This  will  be  an  effective 
redeployment and elimination of duplicative reporting. 

Changes to medical devices regulation will not require any additional resources for 
ECHA.  The  work  is  currently  performed  by  the  Commission  supported  by  the 
SCHEER  committee. The current  resource use is estimated to  be 0.3  FTE per year 
and EUR 24 000 per year. Considering that the envisaged frequency of the work is 
very low, the involvement  of the Committees is  only  where necessary  and the first 
work  will  likely  materialise  only  in  2029,  the  work  can  be  absorbed  by  ECHA 
without any additional resources. 

Changes  to  the  regulation  on  the  EEA  and  to  the  regulation  on  the  general 
principles  and  requirements  of  food  law  and  establishing  the  European  Food 
Safety  Authority  will  have  no  resource  implications.  The  provisions  formalise  the 
activities already performed, they prescribe the  procedural  steps to  follow and they 
enable  the  implementation  of  the  proposal  for  a  regulation  establishing  a  common 
data platform on chemicals, laying down rules to ensure that the data contained in it 
are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals. Any possible resource needs stemming from these 
provisions can be absorbed by the existing resources of the agencies. 

Resource needs for ECHA per legislation amended via the proposal for a Regulation amending Regulations 
(EC) No 178/2002, (EC) No 401/2009, (EU) 2017/754 and (EU) 2019/1021 as regards the reattribution of 
scientific and technical tasks and improving cooperation among Union Agencies in the area of chemicals 

Legislation 

FTEs 

2026 

2025 

Operational costs (in EUR 1 000) 

2027 

2025 

2026 

2027 

TA  CA  TA  CA  TA  CA 

Proposal for a regulation on reattribution of scientific and technical work  

POPs regulation  

Medical devices regulation  

SUM 

1 

0 

1 

0 

0 

0 

2 

0 

2 

0 

0 

0 

2 

0 

2 

0 

0 

0 

35 

0 

35 

50 

0 

50 

50 

0 

50 

Current resource use for technical and scientific work to be  reattributed to ECHA via the proposal for a 
Regulation amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/754 and (EU) 2019/1021 
as  regards  the  reattribution  of  scientific  and  technical  tasks  and  improving  cooperation  among  Union 
Agencies in the area of chemicals 
POPs regulation 
• Technical assistance in reviewing Annexes IV 

and V  

• Hosting POPs monitoring data  
Medical devices regulation  
• Preparation and review of the guidelines on how 
to perform the benefit-risk assessment of the 
presence of phthalates in medical devices 

• Preparation and review of the guidelines on how 
to perform the benefit-risk assessment of the 
presence of CMR and endocrine-disrupting 
substances in medical devices 

Total  ca.  1.5  FTEs/year:  EUR  300  000  for  consultants 
every  3  years  (=1.5  FTE/year);  (In  addition,  DG  ENV  ca. 
0.5 FTE/year (implementing the review of Annexes IV and 
V) whose work will remain) 
Total  ca.  0.3  FTE/year  +  EUR  24  000  per  year:  DG 
SANTE  SCHEER  secretariat  0.3  FTE  (ca.  10%  of 
SCHEER  secretariat  work),  EUR  24  000  per  year  for 
indemnities, 
the 
committee.  (In  addition,  DG  SANTE  (policy  unit)  0.1 
FTE/year whose work will remain).  

travel,  e.g.  costs  for  members  of 

EN 

12 

  EN 

 
 
 
 
 
 
SUM 

0.3  FTEs/year  of  regular  staff;  1.5  FTEs/year  of 
intramurous  contractors  or  interim  staff  (ca.  EUR  100 
000/year); Operational costs of ca. EUR 24 000/year 

In summary, in the first year, there will be a need of 1 FTE (1 TA) and operational 
costs of EUR  35 000 per year and  as  of the second year, there  will be a need of  2 
FTEs  (2  TAs)  per  year  and  operational  budget  of  EUR  50 000  per  year.  All  new 
resources  are  needed  for  ECHA.  Considering  the  resources  currently  used  for  the 
tasks  to  be  reattributed,  there  will  be  a  total  net  increase  in  the  resources  from 
2026 and beyond as compared to today of 0.2 FTEs per year and operational costs 
of EUR 26 000 per year. 

Proposal  for  a  Directive  of  the European  Parliament and  of  the Council 
amending  Directive  2011/65/EU  as  regards  the  re-attribution  of  scientific  and 
technical tasks to the European Chemicals Agency: 

Changes  to  RoHS  directive  will  reattribute  the  assessments  underpinning 
restrictions  of  hazardous  substances  in  electrical  and  electronic  equipment  and 
review of applications for exemptions from the restrictions to ECHA. For this work, 
ECHA will require in the first year 3 FTEs (3 TAs) and operational budget of EUR 
66 000 and as of the second year 7 FTEs (4 TAs + 3 CAs) per year and operational 
budget  of  EUR  33  000 per  year.  The  work  is  currently  performed  with  the  help  of 
consultants and amounts to approximately 2.7 FTE per year. The resources currently 
spent  are  however  insufficient  leading  to  the  accumulation  of  requests  for 
exemptions without processing them to the legal drafting (by December 2022, over 
60  exemption  requests  were  pending)  and  the  revision  of  the  list  of  restricted 
substances  was  delayed  (the  review  not  finalised  although  it  has  started  in  2018). 
There  are  also  complaints  about  the  quality  and  robustness  of  the  assessments,  the 
transparency  of  the  process  and  involvement  of  stakeholders.  The  reattribution  to 
ECHA  and  using  its  processes  will  address  these  shortcomings  and  will  ensure 
alignment  and  coherence  with  other  chemicals  legislation.  The  increase  of  the 
contribution to ECHA will be compensated by a reduction of the LIFE budget. Part 
of these resources  are currently spent  on procuring the contractual support and this 
can be seen as effective redeployment. 

Resource  needs  for  ECHA  for  proposal  for  a  Directive  amending  Directive  2011/65/EU  as  regards  the 
reattribution of scientific and technical tasks to the European Chemicals Agency 

Legislation 

2025 

FTEs 

2026 

Operational costs (in EUR 1 000) 

2027 

2025 

2026 

2027 

TA 

CA 

TA 

CA 

TA 

CA 

RoHS directive  

SUM 

3 

3 

0 

0 

4 

4 

3 

3 

4 

4 

3 

3 

66 

66 

33 

33 

33 

33 

Current resource use for technical and scientific work to be reattributed to ECHA via the proposal for a 
Directive amending Directive 2011/65/EU as regards the reattribution of scientific and technical tasks to the 
European Chemicals Agency 

RoHS directive 

• Assessments underpinning restrictions of  
hazardous substances in electrical and 
electronic equipment  

• Review of applications for exemptions from 

the restrictions 

Total ca. 2.74 FTEs/year: EUR 145 000 annually (on average) for 
outsourcing the review of exemptions (= ca. 2.2 FTEs/year) + a 
contract of EUR 180 000 on average each 5 years for reviewing 
restrictions  (=  0.54  FTE/year).  (In  addition,  DG  ENV  ca.  1.5 
FTE/year  (for  overall  RoHS  implementation)  whose  work  will 
remain) 

EN 

13 

  EN 

 
 
 
SUM 

2.7  FTEs/year  of  intramurous  contractors  or  interim  staff 
(ca. EUR 181 000 per year);  

In summary, in the first year, there will be a need of 3 FTEs (3 TAs) and operational 
budget of EUR 66 000 per year and as of the second year, there will be a need of 7 
FTEs (4 TAs + 3 CAs) per year and operational budget of  EUR 33 000 per year. 
All  new  resources  are  needed  for  ECHA.  Considering  the  resources  currently  used 
for  the  tasks  to  be  reattributed,  there  will  be  a  total  net  increase  in  the  resources 
from  2026  and  beyond  as  compared  to  today  of  4.3  FTEs  per  year  and  EUR 
33 000 per year. 

Proposal  for  a  Regulation  establishing  a  common  data  platform  on  chemicals, 
laying down rules to ensure that the data contained in it are findable, accessible, 
interoperable  and  reusable  and  establishing  a  monitoring  and  outlook 
framework for chemicals:  

The  proposal  will  establish  a  Common  Data  Platform.  It  will  be  established  and 
operated  by  ECHA  with  close  involvement  and  contribution  from  EEA,  EFSA, 
EMA,  EU-OSHA  and  the  Commission.  The  work  will  include  development  and 
operation  of  the  infrastructure  and  the  governance  and  provision  of  data  into  the 
platform. The principal aim of new IT infrastructure operating as part of the Green 
Deal Data Space is to support effective and coherent chemical safety assessments. It 
shall  provide  integrated,  user-differentiated  and  highly  functional  access  to 
chemicals-related datasets owned or managed by EU agencies and provide space for 
legislative 
the  dedicated 
implementation.  

supporting  EU  chemicals  policy  and 

services 

The work will require resources for 4 agencies involved and the Commission (JRC). 
The  resource  requirement  is  higher  for  the  first  3  years  to  set  up  the  infrastructure 
and all the underlying processes to share the data and make them interoperable and in 
adequate formats. This will require for the first 3 years: 

- for ECHA, 10 FTEs (4 TAs + 6 CAs) per year and operational budget of EUR 0 for 
the first year, EUR 2 226 000 for the second year and EUR 2 793 000 for the third 
year; 

- for EEA, 3 FTEs (1 TA + 2 CAs) per year and operational budget of EUR 0 for the 
first year, EUR 266 000  for the second year and EUR 334 000 for the third year;  

- for EFSA, 5 FTEs (5 CAs) per year and an operational budget of EUR 670 000 per 
year. For this purpose, a contribution/service level agreement of EUR 3 000 000 will 
be signed to cover the 3 FTEs (3 CAs) per year and the operational budget needed. 
The  additional  2  FTEs  (2  CAs)  per  year  will  be  financed  from  EFSA’s  current 
budget; 

-  for  EMA,  a  contribution/service  level  agreement  of  EUR  1  400  000  to  cover  3 
FTEs (3 CAs) per year and an operational budget of EUR 100 000 per year;  

- for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year; 

-  for  JRC,  an  administrative  arrangement  for  3  years  of  EUR  540  000  to  cover 
integration of IPCHEM in the common data platform and handing over of IPCHEM 
operation to ECHA.  

EN 

14 

  EN 

After the initial phase of 3 years, the resource requirement is reduced to maintain the 
infrastructure  and  the  underlying  processes  and  to  continue  providing  data.  This 
phase will require  

- for ECHA, 4 FTEs (4 TAs) per year and operational budget of EUR 600 000 per 
year; 

- for EEA, 1 FTE (1 TA) per year and operational budget of EUR 200 000 per year; 

- for EFSA, 2  FTEs (2  CAs) per year  and operational  budget  of EUR 500 000 per 
year; 

- for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year; 

- for EMA, 2 FTEs (2 CAs) per year and operational budget of EUR 0.  

The increases of the contributions to agencies will be compensated by a reduction of 
the  LIFE  budget  except  for  2  FTEs  (2  CAs)  for  EFSA  which  will  be  compensated 
from EFSA’s current budget. 

The  proposal  will  formally  establish  the  Information  Platform  for  Chemical 
Monitoring (IPCHEM) and reattribute its operation to the Agencies. For this work,  

- ECHA will need as of the second year 2 FTEs (1 TA + 1 CA) per year and as of the 
third year operational budget of EUR 180 000 per year; 

- EEA will need as of the first year 1 FTE (1 TA) per year and the operational budget 
in the first year EUR 0, in the second year EUR 200 000, in the third year EUR 200 
000 and as of the fourth year EUR 50 000 per year.  

The operation of IPCHEM is currently done by the Commission and the resource use 
accounts for total of 4.5 FTEs/year. The operation of IPCHEM will be entrusted to 
ECHA  which  will  also  integrated  it  into  the  Common  Data  Platform.  As  the 
operation  of  IPCHEM  will  be  reattributed  to  ECHA,  the  resources  at  the 
Commission’s side will be saved. Hosting of data will be entrusted to the Agencies 
based  on  their  mandates  (ECHA  will  host  occupational  data)  and  EEA  will  host 
indoor  air  data  and  collect  and  host  human  biomonitoring  data.  The  proposal  will 
require  the  agencies  to  provide  occurrence  data  they  hold  to  ECHA  for  the 
integration into IPCHEM.  EFSA already provides data to  IPCHEM and contributes 
to  its  operation  and  will  not  require  any  additional  resources  to  continue  in  this 
activity. EMA and EU-OSHA currently do not systematically collect or receive data 
relevant  for  IPCHEM  and  therefore  will  not  require  any  additional  resources.  The 
increase of the contribution to ECHA and EEA will be compensated by a reduction 
of the LIFE budget. It is therefore a partial redeployment of existing resources.   

legislation  and  provide 

The  proposal  will  establish  a  database  containing  information  on  regulatory 
processes on chemicals on the basis of existing (public) activities coordination tool 
((P)ACT)  and  enlarging  its  scope  to  cover  all  relevant  legislation  with  safety 
assessment  processes  and  initiatives  to  promote  coordination  of  safety  assessment 
activities  across  EU 
the  ongoing 
assessments. This work will impact ECHA, EEA, EFSA and EU-OSHA but will not 
require  additional  resources  for  the  agencies.  ECHA  already  operates  (P)ACT  for 
REACH,  CLP  and  POPs  processes.  EFSA  already  operates  OpenEFSA  which  has 
similar level of information as PACT for food and feed legislation. Resources for the 
operation  and  continuous  provision  of  information  are  to  be  absorbed  by  the 
Agencies  as  part  of  the  existing  processes.  EEA  and  EU-OSHA  are  currently  not 
involved  in  any  processes  relevant  for  the  database,  therefore  no  resources  are 

transparency  on 

EN 

15 

  EN 

required for them. The development and coordination of the system is covered by the 
resources provided for the common data platform.  

The proposal will establish a repository of reference values to promote the reuse of 
existing  reference  values  and  thus  improve  coherence  of  assessments  and  reduce 
repetition  of  deriving  reference  values.  The  proposal  will  impact  ECHA,  EEA, 
EFSA, EMA, EU-OSHA and the Commission. To perform the required work, ECHA 
will need as of the first year 1 FTE (1 TA) per year and operational budget of EUR 0 
in the first year, EUR 650 000 in the second year, EUR 650 000 in the third year and 
as of the fourth year EUR 200 000 per year. No additional resources will be needed 
for  EEA,  EFSA,  EMA,  EU-OSHA  or  the  Commission.  ECHA  has  developed  and 
operates  the  EU  Chemicals  Legislation  Finder  (EUCLEF).  EUCLEF  lists  some 
regulatory  reference  values  derived  and  applicable  under  these  legislative  pieces. 
ECHA will have to collate the ‘old scientific reference values’ which can be done via 
contracting.  The  new  scientific  reference  values  will  be  provided  to  the  repository 
progressively as part of ECHA’s assessment processes. ECHA will require additional 
resources  for  developing,  operating  and  maintain  the  repository,  being  in  contact 
with  data  providers.  EFSA  has  developed  and  is  maintaining  the  OpenFoodTox 
database that summarises the scientific reference values derived by EFSA as part of 
its  assessment  activities.  EFSA  will  continue  its  activity  and  will  provide  the 
information  to  the  new  repository  as  part  of  its  existing  resources.  Therefore,  no 
additional resources are required. EMA will need to provide to the new repository on 
continuous  basis  all  new  predicted  no  effect  concentrations  (PNECs)  derived  for 
human  and  veterinary  medicinal  products  after  entry  into  force  of  this  legislation. 
This  can  be  done  efficiently  as  part  of  EMA’s  future  assessment  activities.  In 
addition,  this  can  be  automatized  for  human  medicines  as  digitalisation  of 
environmental risk assessment is foreseen as part of the revision of human medicinal 
product  legislation.  Therefore,  no  additional  resources  are  required.  EEA  and  EU-
OSHA  currently  do  not  hold  any  relevant  data  for  the  repository.  Therefore,  no 
additional resources are required. The increase of the contribution to ECHA will be 
compensated by a reduction of the LIFE budget. 

The  proposal  will  formalise  establishment  and  operation  of  a  database  with 
information  on  applicable  laws  and  legal  obligations  applicable  to  chemicals 
under  Union  legislation  to  promote  compliance.  This  work  will  impact  ECHA  but 
will not require additional resources under this proposal. ECHA already operates EU 
chemical legislative finder (EUCLEF) as part of the contribution agreement with DG 
GROW. The contribution agreement amounts to ca. EUR 1.0 – 1.4 million annually. 
ECHA runs the service through the employment of 4 interim staff members (ca. EUR 
270 000/year)  and  via  contractors:  communication  activities  and  external  helpdesk 
ca.  EUR  60 000/year,  IT  costs  EUR  200 000/year,  data  costs  EUR  430 000/year. 
These existing resources will be used to continue operating, further developing and 
slightly expanding the system. The resources for major extension of the system, such 
as the repository of reference values,  are provided under the work on repository of 
reference  values.  Although  no  resources  are  required  under  this  proposal,  the 
legislative  proposal  for  a  regulation  on  ECHA  should  address  the  fact  that  the 
operation of the EUCLEF became a structural task for ECHA and that the financing 
should become part of the annual contribution to ECHA.   

The  proposal  will  establish  a  database  on  environmental  sustainability  related 
data on chemicals. The work will impact ECHA. ECHA will be required to set up 
the  database,  operate  it,  establish  and  maintain  the  flows  of  adequate  data  into  the 

EN 

16 

  EN 

database and provide interpretation of data. Other agencies (EEA, EFSA, EMA and 
EU-OSHA), if they host environmental sustainable data on chemicals,  will provide 
that data to ECHA and will cooperate as necessary with ECHA on the development. 
To perform the work, ECHA will need as of the second year 1 FTE (1 TA) per year 
and operational  budget  of EUR 0 per year.  Other agencies will not  need  additional 
resources  as  their  task  is  small,  currently  do  not  actively  collect  any  relevant  data, 
and if they have any of such data, the amount of information held is currently very 
limited.  The  potential  work  on  cooperation  in  this  area  can  be  absorbed  by  the 
agencies’  current  resources.  The  increase  of  the  contribution  to  ECHA  will  be 
compensated by a reduction of the LIFE budget. 

The  proposal  will  establish  data  generation  mechanism  to  allow  ECHA  and  the 
Commission  to  commission  studies  supporting  the  implementation  of  Union 
chemicals legislation within ECHA’s mandate or contributing to the development of 
Union chemicals policy. The studies can be commissioned only when results cannot 
be  obtained  through  existing  legal  provisions  and  they  shall  not  have  predominant 
research  and  development  objective.  The  mechanism  will  allow  ECHA  and  the 
Commission  to  generate  data  where  needed  and  cannot  be  obtained  otherwise. 
ECHA’s  involvement  is  necessary  as  commissioning  of  such  studies  requires 
technical expertise. To perform the work, ECHA will require in the first year 1 FTE 
(1 TA) and operational budget of EUR 0, in the second year 2 FTEs (1 TA and 1 CA) 
and operational budget of EUR 1 000 000, in the third year 2 FTEs (1 TA and 1 CA) 
and operational  budget  of EUR 3 000 000 and as of the fourth  year 2  FTEs (1 TA 
and 1 CA) per year and operational budget of EUR 5 000 000 per year.  No current 
process exists, but there is a complementary process operated by EFSA for the food 
sector (4 FTEs/year, EUR 15 000 000/year). This will continue to be operated next to 
the  new  one  and  the  two  Agencies  (ECHA  and  EFSA)  are  required  to  cooperate 
when  commissioning  such  studies  and  develop  a  joint  plan.  The  increase  of  the 
contribution to ECHA will be compensated by a reduction of the LIFE budget.  

The proposal will expand the obligation to notify studies before they start from food 
sector  to  all  chemical  sector.  The  work  will  require  additional  resource  for  ECHA. 
ECHA  will  need  as  of  the  first  year  3  FTEs  (1  TA  and  2  CAs)  per  year  and 
operational budget in the first year of EUR 0, in the second year EUR 1 200 000, in 
the third year EUR 400 000 and as of the fourth year EUR 200 000 per year. ECHA 
will be required to develop the database, operate it, facilitate and check compliance 
with the provisions and provide feedback to the duty holders. EFSA already operates 
a  database  of  notification  of  studies  to  serve  the  obligation  under  the  food  sector 
legislation. The resource use amounts to 2 FTEs/year and EUR 400 000/year. EFSA 
and  ECHA  will  be  required  to  ensure  compatibility  of  the  systems.  No  additional 
resources are needed for this for EFSA. The increased contribution to ECHA will be 
compensated by a reduction of the LIFE budget.  

The  proposal  will  formalise  the  operation  of  the  indicators  framework  for 
chemicals  and  will  establish  an  early  warning  and  action  system  for  chemicals. 
The  work  will  require  additional  resources  for  EEA.  EEA  will  need  as  of  the  first 
year 1 FTE (1 TA) per year and operational budget for the first year of EUR 0, for 
the second year EUR 300 000 and as of the third year EUR 150 000 per year. EEA 
and ECHA already jointly develop the indicators framework for chemicals as part of 
the commitment under the 8th Environment Action Programme. As the resources for 
indicator  framework  (2  FTEs  per  year  for  ECHA,  1  FTE  per  year  for  EEA)  were 
already attribution as part of the 8th EAP, no additional resources are needed for this 

EN 

17 

  EN 

work.  The  establishment  of  the  early  warning  and  action  system  is  a  new,  non-
existing  task  that  aims  to  significantly  shorten  the  regulatory  response  to  identified 
risks. The EEA will be tasked to collect early warning signals from other agencies, 
Member State and by its own activity and compile annually a report for discussion 
and  decision  on  the  follow  up  with  Member  States  authorities.  The  increased 
contribution to EEA will be compensated by a reduction of the LIFE budget. Other 
contributing agencies (ECHA, EFSA, EMA and EU-OSHA) will absorb the costs as 
part of exiting activities. In case of ECHA, the resources attribution for the indicator 
framework  will  be  partly  used  to  support  the  EEA  by  generating  relevant  early 
warning  signals.  The  increased  contribution  to  EEA  will  be  compensated  by  a 
reduction of the LIFE budget. 

The  proposal  will  establish  an  observatory  for  specific  chemicals  with  potential 
contribution to emerging chemical risks. This will de facto formalise the operation 
of  existing  EU  Observatory  for  nanomaterials  and  extend  its  scope  to  specific 
chemicals considered to benefit from additional scrutiny and reliable information on 
their  properties,  safety  aspects,  uses  and  market  presence.  This  work  will  impact 
ECHA but will not require additional resources under this proposal. ECHA operates 
the EU Observatory for nanomaterials as part of a contribution agreement with DG 
GROW.  The  resource  use  amounts  to  approximately  EUR  700 000  per  year 
including  the  3  FTEs  (3  CA).  These  existing  resources  will  be  used  to  continue 
operating,  further  developing  and  slightly  expanding  the  system.  The  legislative 
proposal  in  preparation  for  a  regulation  on  ECHA  will  address  the  fact  that  the 
operation of the EUCLEF became a structural task for ECHA and that the financing 
should become part of the annual contribution to ECHA.   

Resource needs per activity for the proposal for a Regulation establishing a common data platform on 
chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable 
and reusable and establishing a monitoring and outlook framework for chemicals 

Activity 

Common data platform  

Information  Platform  for  Chemical  Monitoring 
(IPCHEM) 
Information  on 
chemicals 
Repository of reference values  

regulatory  processes  on 

Information on the obligations under Union acts 
on chemicals 
Environmental  sustainability  related  data  on 
chemicals 
Data generation mechanism 

Mechanism  for  notification  of  studies  and 
database for study notifications 
Early  warning  and  action  system  for  emerging 
chemical risks and framework of indicators 
specific  chemicals  with 
Observatory 
potential  contribution  to  emerging  chemical 
risks  
SUM 

for 

FTEs 

2025 

2026 
TA  CA  TA  CA  TA  CA 
16 

2027 

16 

16 

5 

5 

5 

1 

0 

1 

0 

0 

1 

1 

1 

0 

0 

0 

0 

0 

0 

0 

2 

0 

0 

2 

0 

1 

0 

1 

1 

1 

1 

0 

1 

0 

0 

0 

0 

1 

2 

0 

0 

2 

0 

1 

0 

1 

1 

1 

1 

0 

1 

0 

0 

0 

0 

1 

2 

0 

0 

Operational costs  
(in EUR 1 000) 
2026 

2025 

2027 

950 

3 442 

4 077 

0 

0 

0 

0 

0 

0 

0 

0 

0 

200 

380 

0 

0 

650 

650 

0 

0 

0 

0 

1 000 

3 000 

1 200 

400 

300 

150 

0 

0 

10 

18 

12 

20 

12 

20 

950 

6 792 

8 657 

Resource needs per agency/service for the proposal for a Regulation establishing a common data platform 

EN 

18 

  EN 

 
 
 
 
 
 
 
 
 
on  chemicals,  laying  down  rules  to  ensure  that  the  data  contained  in  it  are  findable,  accessible, 
interoperable and reusable and establishing a monitoring and outlook framework for chemicals 

2025 

FTEs 
2026 

2027 

Agency / Service 
ECHA 
EEA 
EFSA 
EMA 
EU OSHA 
JRC 
SUM 

TA 
7 
3 
0 
0 
0 
0 
10  

CA 
8 
2 
5 
3 
0 
0 
18 

TA 
9 
3 
0 
0 
0 
0 
12 

CA 
10 
2 
5 
3 
0 
0 
20 

TA 
9 
3 
0 
0 
0 
0 
12 

CA 
10 
2 
5 
3 
0 
0 
20 

Operational costs (in EUR 1 000) 
2027 

2025 

2026 

0  
0  
670  
100  
0 
180  
950 

5 076  
766 
670  
100  
0 
180  
6 792 

7 023  
684  
670  
100  
0 
180  
8 657  

Current resource use for technical and scientific work to be reattributed to Agencies as part of the proposal 
for a Regulation  establishing a common data platform on chemicals, laying down rules to ensure that the 
data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and 
outlook framework for chemicals 

IPCHEM 

Total  4.5  FTEs/year:  DG  JRC  staff  2.5  FTEs/year  +  IT  experts 
intramurous 2 FTEs/year (EUR 130 000 per year). 

Information on regulatory processes 
on chemicals 

ECHA already operates (P)ACT for REACH, CLP and POPs processes. 
EFSA  already  operates  OpenEFSA  which  has  a  similar  level  of 
information  as  PACT.  Resources  for  the  operation  and  continuous 
provision of information are to be absorbed by the Agencies. 

Information on the obligations under 
Union acts on chemicals  

ECHA  already  operates  EUCLEF  and  this  is  financed  through  the 
contribution  agreement  between  DG  GROW  and  ECHA.  No  additional 
resources needed but the formalisation of the resource allocation  should 
be done by the proposal for regulation on ECHA. 

Observatory for specific chemicals 
with potential contribution to 
emerging chemical risks  

ECHA already operates the EU Observatory on Nanomaterials and this is 
financed via the contribution agreement between DG GROW and ECHA. 
No  additional  resources  needed  but  the  formalisation  of  the  resource 
allocation should be done by the proposal for a regulation on ECHA. 

SUM 

2.5  FTEs/year  of  regular  staff;  2  FTEs/year  of  intramurous 
contractors or interim staff (ca. EUR 130 000/year) 

In  summary,  the  legislative  proposal  on  chemicals  data  consists  of  10  distinct 
activities that will have an impact on resource needs of ECHA, EEA, EFSA, EMA 
and the Commission. The first three years there will be a need of up to 32 FTEs (12 
TA + 20 CA) per year and an operational budget of up to EUR 8 657 000 per year. 
In the fourth year and beyond, there will be a need of 20 FTEs (12 TA and 8 CA) 
per year and an operational budget of EUR 7 080 000 per year. It must be noted that 
some activities included in  the calculation above already exists and are financed as 
part  of  existing  core  ECHA  and  EFSA  work  (such  as  (P)ACT),  through  the 
contribution agreements between GROW and ECHA (EUCLEF and EU Observatory 
for  nanomaterials)  or  from  JRC  core  activities  (IPCHEM).  Resources  for  the 
operation  of  (P)ACT  and  OpenEFSA  portal  that  should  feed  into  the  extended 
version  of  (P)ACT  will  be  used  to  absorb  the  expansion  of  the  (P)ACT  for  other 
pieces of legislation, including the merge of OpenEFSA into (P)ACT. Resources for 
the  operation  of  EUCLEF  and  EUON  will  be  used  to  continue  operation, 
development  and  slight  expansion  of  the  systems,  while  the  fact  that  that  the 
operation  of  the  EUCLEF  and  EUON  became  a  structural  task  for  ECHA  and  that 
there is a need to ensure that the financing should be part of the annual contribution 
to ECHA will be addressed in the proposal for a regulation on ECHA. Therefore for 

EN 

19 

  EN 

 
 
 
 
 
 
this  part  of  work  no  additional  resources  are  required  under  this  proposal.  The 
resources currently used for the operation of IPCHEM consists of  2.5 FTEs/year of 
regular staff, 2 FTEs of intramurous contractors (EUR 130 000 per year). As this task 
will be reattributed, the current resources used for this task will not be needed by the 
Commission.  Therefore,  the  total  net  increase  in  the  resources  from  2028  and 
beyond as compared to today will be 15.5 FTEs per year and operational budget of 
EUR 7 080 000 per year. 

Proposal for a Regulation on packaging and packaging waste (COM (2022) 677 
final):  

In  theory,  national  legislations  in  Member  States  could  have  been  established. 
However, there would have been to guarantee of consistent application across the EU 
and would inevitably contribute to further fragmentation of the internal market. 

Tasks related to development of legislation at the EU level cannot be externalised. 

The proposal attributes the task to ECHA to perform a scoping study on chemical in 
packaging  that  would  be  candidates  for  restriction.  This  is  a  new  process  that  will 
require 1 FTE (1 TA) per year for 3 years in ECHA. The increased contribution to 
ECHA will be compensated by a reduction of the LIFE budget. 

Resource needs for ECHA for proposal for a Regulation on packaging and packaging waste (COM (2022) 
677 final) 

Legislation 

FTEs 

2026 

2025 

Operational costs (in EUR 1 000) 

2027 

2025 

2026 

2027 

Packaging and packaging waste  

SUM 

TA  CA  TA  CA  TA  CA 

1 

1 

0 

0 

1 

1 

0 

0 

1 

1 

0 

0 

0 

0 

0 

0 

0 

0 

Proposal for a directive amending waste framework directive (COM (2023) 420 
final):  

The  proposal  lays  down  changes  in  the  reporting  requirements  of  Member  States 
with  regard  to  the  re-use  of  products  data  flow  to  the  European  Environmental 
Agency. The enhanced reporting requirements will require 1 FTE (1 TA) per year in 
EEA. The increased contribution to EEA will be compensated by a reduction of the 
LIFE budget. 

Resource needs for EEA for proposal for a Directive amending waste framework directive (COM (2023) 
420 final) 

Legislation 

2025 

FTEs 

2026 

Operational costs (in EUR 1 000) 

2027 

2025 

2026 

2027 

Waste framework directive  

SUM 

TA  CA  TA  CA  TA  CA 

1 

1 

0 

0 

1 

1 

0 

0 

1 

1 

0 

0 

0 

0 

0 

0 

0 

0 

Proposal for a Regulation on circularity requirements for vehicle design and on 
management of end-of-life vehicles (COM (2023) 451 final): 

ECHA  support  is  required  for improving  the  risk  assessment  of  the  remaining 
hazardous substance exemptions, in particular for reviewing the scope extension and 
potential  wider  coverage  of  substances  of  concern  (1  FTE  (1  TA)  per  year  for 
ECHA). The increased contribution to ECHA will be compensated by a reduction of 
the LIFE budget. 

EN 

20 

  EN 

 
 
 
 
Resource  needs  for  ECHA  for  proposal  for  a  Regulation  on  circularity  requirements  for  vehicle  design 
and on management of end-of-life vehicles (COM (2023) 451 final)  

Legislation 

2025 

FTEs 

2026 

Operational costs (in EUR 1 000) 

2027 

2025 

2026 

2027 

End-of-life vehicles regulation 

SUM 

TA  CA  TA  CA  TA  CA 

1 

1 

0 

0 

1 

1 

0 

0 

1 

1 

0 

0 

0 

0 

0 

0 

0 

0 

EN 

21 

  EN 

 
 
 
 
 
1.6. 

Duration and financial impact of the proposal/initiative 

 limited duration  

–    in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–    Financial  impact  from  YYYY  to  YYYY  for  commitment  appropriations  and 

from YYYY to YYYY for payment appropriations.  

 unlimited duration 

–  Implementation with a start-up period from 2025 to 2028, 

–  followed by full-scale operation. 

1.7.  Method(s) of budget implementation planned61  

 Direct management by the Commission 

–   by its departments, including by its staff in the Union delegations;  

–    by the executive agencies  

 Shared management with the Member States  

 Indirect management by entrusting budget implementation tasks to: 

–   third countries or the bodies they have designated; 

–   international organisations and their agencies (to be specified); 

–   the EIB and the European Investment Fund; 

–   bodies referred to in Articles 70 and 71 of the Financial Regulation; 

–   public law bodies; 

–   bodies governed by private law with a public service mission to the extent that 

they are provided with adequate financial guarantees; 

–   bodies governed by the private law of a Member State that are entrusted with 
the  implementation  of  a  public-private  partnership  and  that  are  provided  with 
adequate financial guarantees; 

–   bodies or persons entrusted with the implementation of specific actions in the 
CFSP pursuant to Title V of the TEU, and identified in the relevant basic act. 

– 

If more than one management mode is indicated, please provide details in the ‘Comments’ section. 

61 

Details of budget implementation methods and references to the Financial Regulation may be found on 
the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-
implementation/Pages/implementation-methods.aspx 

EN 

22 

  EN 

 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

This  Legislative Financial  Statement includes  an increase of the contribution to  the 
ECHA and  the EEA,  and contribution/service level  agreements with  the EFSA and 
the EMA.  

The  Commission  will  be  overall  accountable  for  implementing  the  proposed 
Regulation  as  well  as  for  reporting  to  the  European  Parliament  and  the  Council  on 
implementation and compliance. The  agencies will report on the implementation of 
their contributions and of the related actions in their annual activity reports. 

2.2.  Management and control system(s)  

2.2.1. 

Justification of the management mode(s), the funding implementation mechanism(s), 
the payment modalities and the control strategy proposed 

This  Legislative Financial  Statement includes  an increase of the contribution to  the 
ECHA and  the EEA,  and contribution/service level  agreements with  the EFSA and 
the EMA.  

DG Environment, in the context of its supervision of decentralised entities, and  the 
agencies will apply its respective control strategies to this expenditure.  

2.2.2. 

Information concerning the risks identified and the internal control system(s) set up 
to mitigate them 

While  the  Commission  will  be  overall  accountable  for  implementing  the  proposed 
Regulation  as  well  as  for  reporting  to  the  European  Parliament  and  the  Council  on 
the  implementation  and  compliance,  the  additional  resources  put  at  the  disposal  of 
the agencies will be covered by their internal control and risk management systems 
that are aligned with the relevant international standards. DG Environment will apply 
the controls related to its supervision of decentralised agencies. No specific risks are 
identified in relation with the implementation of the additional budget to be provided 
to the agencies. 

2.2.3.  Estimation and justification of the cost-effectiveness of the controls (ratio of "control 
costs ÷ value of the related funds managed"), and assessment of the expected levels 
of risk of error (at payment & at closure)  

The  risk  of  error  at  payment  and  at  closure  is  expected  to  remain  under  2%.  The 
agencies  are  full  responsibility  over  the  implementation  of  their  budget,  while  DG 
Environment is responsible for the regular payment of the contributions. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy. 

In  addition  to  the  controls  stemming  from  the  control  strategie  listed  above,  the 
action is subject to scrutiny of the Internal Audit Service, in its capacity of internal 
auditor  of  the  Commission  and  of  the  decentralised  agencies,  and  of  the  European 
Court of Auditors, in its capacity of external auditor of the EU Institutions.  

EN 

23 

  EN 

The  Commission  maintains  robust  antifraud  strategy,  the  CAFS,  that  is  currently 
under revision. DG Environment complements this by a local antifraud strategy that 
covers the activities falling under its remit.  

EN 

24 

  EN 

3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

•  Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of  
expenditur
e 

Contribution  

Heading of 
multiannua
l financial 
framework 

Number  

3 

3 

3 

09.0202  –  LIFE  Circular  Economy  and 
Quality of Life 

09.10.01  European  Chemicals  Agency  – 
environmental  directives  and  international 
conventions 

09.10.02  European  Environment  Agency 
(ENV) 

•  New budget lines requested  

Diff./Non-
diff.62 

from 
EFTA 
countries
63 

from 
candidate 
countries 
and 
potential 
candidates
64 

fromother 
third 
countries 

other assigned 
revenue 

Diff 

YES 

YES 

NO 

NO 

Diff 

YES 

NO 

NO 

NO 

Diff 

YES 

YES 

YES 

NO 

In order of multiannual financial framework headings and budget lines. 

N/A

62 
63 
64 

Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidates from the Western Balkans. 

EN 

25 

  EN 

 
 
3.2. 

Estimated financial impact of the proposal on appropriations  

3.2.1. 

Summary of estimated impact on operational appropriations  

–    The proposal/initiative does not require the use of operational appropriations  

–    The proposal/initiative requires the use of operational appropriations, as explained below: 

Heading of multiannual financial  
framework  

Number  Heading 3 (Natural resources and environment) 

EUR million (to three decimal places) 

Agency: ECHA – Environmental 
Directives 

Title 1: Staff expenditure  

Title 2: Infrastructure 

Title 3: Operational expenditure 

Commitments 

Payments 

Commitments 

Payments 

Commitments 

Payments 

(1a) 

(2a) 

(1b) 

(2b) 

(1c) 

(2c) 

TOTAL appropriations 
for agency ECHA 

Commitments 

=1a + 1b + 1c 

Payments 

=2a + 2b + 2c 

2024 

2025 

2026 

2027 

TOTAL 

0 
0 

0 
0 

0 

0 

1,765 
1,765 

4,991 
4,991 

5,091 
5,091 

0,101 
0,101 

1,866 

5,159 
5,159 

7,106 
7,106 

10,150 

12,197 

1,866 

10,150 

12,197 

11,848 
11,848 

12,366 
12,366 

24,214 

24,214 

The details of the tasks to be performed by ECHA are specified in the staff working document65 accompanying this legal proposal, in particular 
in the Annexes III and IV. The above increase of the contribution to ECHA will be offset from the LIFE Programme (budget line: 09.02.02).  

65 

SWD (2023) 850 

EN 

26 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Agency: EEA 

Title 1: Staff expenditure  

Title 2: Infrastructure 

Title 3: Operational expenditure 

Commitments 

Payments 

Commitments 

Payments 

Commitments 

Payments 

(1a) 

(2a) 

(1b) 

(2b) 

(1c) 

(2c) 

TOTAL appropriations 
for agency EEA 

Commitments 

=1a + 1b + 1c 

Payments 

=2a + 2b + 2c 

2024 

2025 

2026 

2027 

TOTAL 

0 
0 

0 
0 

0 

0 

0,595 
0,595 

1,214 
1,214 

1,238 
1,238 

0 
0 

0,595 

0,766 
0,766 

1,980 

0,684 
0,684 

1,922 

0,595 

1,980 

1,922 

3,046 
3,046 

1,450 
1,450 

4,496 

4,496 

The details of the tasks to be performed by EEA are specified in the staff working document66 accompanying this legal proposal, in particular in 
the Annexes III and IV. The above increase of the contribution to the EEA will be offset from the LIFE Programme (budget line: 09.02.02).  

DG: ENV 

Budget line: 
09.02.02 

2024 

2025 

2026 

2027 

TOTAL 

Contribution/Service 
with EFSA 

Contribution/Service 
with EMA 

level  agreement 

Commitments 

Payments 

level  agreement 

Commitments 

Payments 

Commitments 

Payments 

Commitments 

Payments 

Administrative arrangements with JRC 

 TOTAL operational appropriations  

66 

SWD (2023) 850 

EN 

(1a) 

(2a) 

(1b) 

(2b) 

(1b) 

(2b) 

(4) 

(5) 

1,000 

1,000 

0,467 

0,467 

1,000 
1,000 

0.467 

0.467 

1,000 
1,000 

0.467 

0.467 

0,180 

0,180 

0,180 

0,180 

1,580 

1,580 

0,180 

1,580 

1,580 

0,180 

1,580 

1,580 

- 

- 

- 

- 

- 

- 

- 

- 

27 

3,000 

3,000 

1,400 

1,400 

0,540 

0,540 

4,740 

4,740 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(6) 

TOTAL appropriations  

Commitments 

=4+ 6 

for DG ENV 

Payments 

=5+ 6 

- 

- 

1,647 

1,647 

1,647 

1,647 

1,647 

1,647 

4,940 

4,940 

The  need  for  additional  resources  for  EFSA  is  estimated  at  3  contract  agents  and  EUR  2  million  of  operational  expenditure.  The  need  for 
additional resources for EMA is estimated at 3 contract agents and EUR 0,3 million of operational expenditure. For 2025-2027, these costs will 
be covered through a contribution/service level agreement between the agencies and DG ENV. Without prejudice to the future MFF agreement, 
the costs from 2028 on should be covered by the EU subsidies to these agencies.   

In addition, the need for additional resources for JRC is estimated at EUR 0,540 million of operational expenditure, to be channelled through an 
administrative agreement.  

2024 

2025 

2026 

2027 

TOTAL 

  TOTAL  operational  appropriations  (all 
operational headings) 

Commitments 

Payments 

 TOTAL appropriations of an administrative nature financed 
from  the  envelope  for  specific  programmes  (all  operational 
headings) 

TOTAL appropriations  
under HEADINGS 1 to 6 
of the multiannual financial framework 
(Reference amount) 

Commitments 

Payments 

(4) 

(5) 

(6) 

=4+ 6 

=5+ 6 

EN 

4,108 

13,777 

15,766 

4,108 

13,777 

15,766 

33,650 

33,650 

0 

0 

28 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial  
framework  

7 

‘Administrative expenditure’ 

This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative 
Financial Statement (Annex 5 to the Commission decision on the internal rules for the implementation of the Commission section of the general 
budget of the European Union), which is uploaded to DECIDE for interservice consultation purposes. 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as 
necessary to show the duration 
of the impact (see point 1.6)  

TOTAL 

EUR million (to three decimal places) 

DG: <…….> 

 Human resources  
 Other administrative expenditure  

TOTAL DG <…….> 

Appropriations  

TOTAL appropriations 
under HEADING 7 
of the multiannual financial framework  

(Total  commitments  = 
Total payments) 

2024 

2025 

2026 

2027 

TOTAL 

EUR million (to three decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 7 
of the multiannual financial framework  

Commitments 

Payments 

0 

0 

4,108 

13,777 

15,766 

4,108 

13,777 

15,766 

33,650 

33,650 

EN 

29 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated output funded with operational appropriations  

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

OUTPUTS 

Commitment appropriations in EUR million (to three decimal places) 

Enter as many years as necessary to show the 
duration of the impact (see point 1.6) 

TOTAL 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost  N

o

Cost 

o
N

Cost 

Total 
No 

Total 
cost 

Indicate 
objectives and 
outputs  

 

Type67 

Avera
ge 
cost 

SPECIFIC OBJECTIVE No 168… 

- Output 

- Output 

- Output 

Subtotal for specific objective No 1 

SPECIFIC OBJECTIVE No 2 ... 

- Output 

Subtotal for specific objective No 2 

TOTALS 

67 
68 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 
As described in point 1.4.2. ‘Specific objective(s)…’  

EN 

30 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.  Estimated  impact  on  ECHA,  EEA,  EFSA  and  EMA  human  resources  and 

administrative appropriations  

3.2.3.1.  Estimated requirements on ECHA’s human resources  

–    The proposal/initiative does not require the use of human resources.  

–    The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

EUR million (to three decimal places)  

Where applicable, amounts reflect the sum of the Union contribution to the agency and other revenue of the agency (fees and 
charges).  

2023  

2024  

2025  

2026  

2027 

TOTAL  

Temporary agents (AD 
Grades)  

Temporary 
(AST grades)  

agents 

Contract staff  

Seconded National 
Experts  

TOTAL  

Staff requirements (FTE):  

-  

-  

-  

-  

-  

-  

-  

-  

-  

- 

1,330  

3,548  

3,619  

8,496  

-  

-  

-  

-  

0,436  

1,444  

1,473  

3,352  

-  

-  

-  

-  

1,765  

4,991  

5,091  

11,848  

2023  

2024  

2025  

2026  

2027 

TOTAL  

Temporary agents (AD 
Grades)  

Temporary agents 
(AST grades)  

Contract staff  

Seconded National 
Experts  

TOTAL  

-  

-  

-  

-  

-  

-  

-  

-  

-  

13  

-  

8  

-  

17  

-  

13  

-  

17  

-  

13  

-  

-   

21  

30  

30  

3.2.3.2.  Estimated requirements on EEA’s human resources  

–    The proposal/initiative does not require the use of human resources.  

–    The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

EUR million (to three decimal places)  

EN 

31 

  EN 

 
  
  
  
  
  
  
  
  
  
  
  
  
 
Where applicable, amounts reflect the sum of the Union contribution to the agency and other revenue of the agency (fees and 
charges).  

2023  

2024  

2025  

2026  

2027 

TOTAL  

Temporary agents (AD 
Grades)  

Temporary agents 
(AST grades)  

Contract staff  

Seconded National 
Experts  

-  

-  

-  

-  

- 

-  

- 

-  

0,470 

0,959 

0,978 

2,406  

-  

-  

-  

-  

0,125 

0,255 

0,260 

0,640  

-  

-  

-  

TOTAL  

0,595  

1,214  

1,238  

3,046  

Staff requirements (FTE):  

2023  

2024  

2025  

2026  

2027 

TOTAL  

Temporary agents (AD 
Grades)  

Temporary agents 
(AST grades)  

Contract staff  

Seconded National 
Experts  

TOTAL  

-  

-  

-  

-  

-  

-  

-  

-  

4  

-  

2  

- 

6  

4  

-  

2  

-  

6  

4  

-  

2  

-  

6  

3.2.3.3.  Estimated requirements on EMA’s human resources  

–    The proposal/initiative does not require the use of human resources.  

–    The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Staff requirements (FTE):  

2025  

2026  

2027  

Temporary agents (AD 
Grades)  

Temporary agents 
(AST grades)  

-  

-  

-  

-  

EN 

32 

  EN 

 
  
  
  
  
  
 
  
  
  
  
  
  
  
  
  
  
  
 
  
  
 
 
Contract staff  

Seconded National 
Experts  

TOTAL  

3 

-  

3  

3  

- 

3 

3  

-  

3 

3.2.3.4.  Estimated requirements on EFSA’s human resources  

–    The proposal/initiative does not require the use of human resources.  

–    The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Staff requirements (FTE):  

2025  

2026  

2027  

Temporary agents (AD 
Grades)  

Temporary agents 
(AST grades)  

Contract staff  

Seconded National 
Experts  

TOTAL  

-  

-  

5 

-  

5 

-  

5  

- 

5 

-  

5  

-  

5 

EN 

33 

  EN 

 
  
 
  
  
 
 
  
 
3.2.4.  Compatibility with the current multiannual financial framework  

The proposal/initiative: 

–    can be fully financed through redeployment within the relevant heading of the 

Multiannual Financial Framework (MFF). 

The  increases  of  the  agencies  subsidies  will  be  offset  from  the  LIFE  programme 
except  2  FTEs  (2  CAs)  for  EFSA  which  will  be  financed  from  EFSA’s  current 
budget as detailed above.  

–    requires use of the unallocated margin under the relevant heading of the MFF 

and/or use of the special instruments as defined in the MFF Regulation. 

–    requires a revision of the MFF. 

3.2.5.  Third-party contributions  

The proposal/initiative: 

–    does not provide for co-financing by third parties 

–    provides for the co-financing by third parties estimated below: 

Appropriations in EUR million (to three decimal places) 

Year 
N69 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as necessary 
to show the duration of the 
impact (see point 1.6) 

Total 

Specify  the  co-financing 
body  

TOTAL appropriations 
co-financed  

69 

Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the 
expected first year of implementation (for instance: 2021). The same for the following years. 

EN 

34 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.3. 

Estimated impact on revenue  

–    The proposal/initiative has no financial impact on revenue. 

–    The proposal/initiative has the following financial impact: 

– 

– 

– 

 

 

on own resources  

on other revenue 

please indicate, if the revenue is assigned to expenditure lines  

Appropriations 
available for 
the current 
financial year 

Budget revenue line: 

Article …………. 

     EUR million (to three decimal places) 

Impact of the proposal/initiative70 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

Enter as many years as necessary to show 
the duration of the impact (see point 1.6) 

For assigned revenue, specify the budget expenditure line(s) affected. 

Other  remarks  (e.g.  method/formula  used  for  calculating  the  impact  on  revenue  or  any  other 
information). 

70 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 20 % for collection costs. 

EN 

35 

  EN